Helical anchor implantation

ABSTRACT

A transluminal sheath is advanced transseptally into a left atrium of the subject. A distal end of a surrounding-sheath, having an anchor disposed therein, is advanced via a distal end of the transluminal sheath, into a left ventricle of the subject via a commissure of the mitral valve. While the distal end of the surrounding-sheath is in the left ventricle, the surrounding-sheath is pulled proximally with respect to the anchor to expose the anchor. While the distal end of the surrounding-sheath is in the left ventricle, mitral valve tissue that is within the left ventricle is encircled by helically wrapping the anchor around the mitral valve tissue. Subsequently, the surrounding-sheath is extracted from the heart. Other embodiments are also described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims priority and is a continuation-in-partof:

-   -   (a) U.S. Ser. No. 12/840,463 to Hacohen, filed Jul. 21, 2010,        entitled “Guide wires with commissural anchors to advance a        prosthetic valve,”    -   (b) U.S. Ser. No. 13/033,852 to Gross, filed Feb. 24, 2011,        entitled “Techniques for percutaneous mitral valve replacement        and sealing,” which is a continuation-in-part of U.S. Ser. No.        12/840,463 to Hacohen; and    -   claims priority from U.S. Provisional Patent Application        61/492,449 to Gross, filed Jun. 2, 2011, entitled, “Techniques        for percutaneous mitral valve replacement and sealing.”    -   All of the above-referenced applications are incorporated herein        by reference.

FIELD OF THE INVENTION

Embodiments of the present invention relate in general to valvereplacement. More specifically, embodiments of the present inventionrelate to prosthetic valves for replacement of an atrioventricularvalve.

BACKGROUND

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Regurgitation of bloodfrom the ventricle into the atrium results in increased total strokevolume and decreased cardiac output, and ultimate weakening of theventricle secondary to a volume overload and a pressure overload of theatrium. Dilation of the annulus is sometimes treated by implanting aprosthetic mitral valve at a patient's native mitral valve.

SUMMARY

For some applications of the present invention, one or more guidemembers (e.g., wires, sutures, or strings) is configured to be anchoredto respective commissures of a native atrioventricular valve of apatient, and each guide member facilitates the advancement therealong ofrespective commissural anchors. The commissural anchors are shaped so asto define a plurality of barbs or prongs which are expandable torestrict proximal movement of the anchors following their deployment.The guide members facilitate advancement of a collapsible prostheticvalve support (e.g., a skirt) which serves as a base for and receives acollapsible prosthetic mitral valve which is subsequently coupled to thesupport. The support comprises a proximal annular element, or ring, anda distal cylindrical element. The cylindrical element is configured topush aside and press against the native leaflets of the native valve,and the proximal annular element is shaped so as to define one or moreholes for sliding the valve support along the one or more guide members.The proximal annular element is configured to be positioned along theannulus of the native valve.

The collapsible prosthetic valve is configured for implantation inand/or at least partial replacement (e.g., full replacement) of thenative atrioventricular valve of the patient, such as a native mitralvalve or a native tricuspid valve. The valve support and the prostheticvalve are configured to assume collapsed states for minimally-invasivedelivery to the diseased native valve, such as by percutaneous ortransluminal delivery using one or more catheters. For someapplications, the valve support and the prosthetic valve are implantedduring an open-heart procedure.

The prosthetic valve support is shaped so as to define a downstreamskirt. The downstream skirt is configured to be placed at native valve,such that the downstream skirt passes through the orifice of the nativevalve and extends toward, and, typically partially into, a ventricle.The downstream skirt typically additionally pushes aside and pressesagainst the native leaflets of the native valve, which are left in placeduring and after implantation of the prosthetic valve support and/or theprosthetic valve.

The proximal annular element has upper and lower surfaces. For someapplications of the present invention, one or more, e.g., a pluralityof, tissue anchors are coupled to the lower surface and facilitateanchoring of the proximal annular element to the annulus of the nativevalve. For some applications, the one or more anchors comprise at leastfirst and second commissural anchors that are configured to be implantedat or in the vicinity of the commissures of the native valve.

The cylindrical element of the valve support has first and second endsand a cylindrical body disposed between the first and second ends. Thefirst end of the cylindrical element is coupled to the annular elementwhile the second end defines a free end of the cylindrical element. Forsome applications of the present invention, the cylindrical element ofthe valve support is invertible such that (1) during a first period, thesecond end and the cylindrical body of the cylindrical element aredisposed above the annular element (e.g., in the atrium of the heart),and (2) during a second period, the second end and the cylindrical bodyof the cylindrical element are disposed below the annular element (e.g.,in the ventricle of the heart).

For some applications, techniques are applied to facilitate sealing ofthe interface between the valve support and the native valve, and/or theinterface between the prosthetic valve and the native valve. Forexample, a sealing balloon may be placed on a valve-facing, lower sideof the annular element of the valve support, the sealing balloon beingconfigured to be inflated such that the balloon seals the interfacebetween the valve support and the native valve. Alternatively oradditionally, commissural helices are wrapped around chordae tendineaeof the patient in order to facilitate sealing of the valve commissuresaround the valve support and/or around the valve. Further alternativelyor additionally, the valve commissures are grasped by grasping elementsthat act in order to facilitate sealing of the commissures around thevalve support and/or around the valve. For some applications, one ormore of the aforementioned sealing elements facilitates anchoring of theprosthetic valve to the native valve in addition to facilitatingsealing.

For some applications, the prosthetic valve comprises an expandableframe (e.g., a wire frame), and a sealing material (such as latex) isdisposed on the outer surface of the frame so as to form webbing betweenat least some of the struts of the wire frame, and to provide sealingbetween the wire frame and the native valve.

For some applications, an invertible prosthetic valve support is used tosupport a prosthetic valve. Typically, a sealing element is disposedcircumferentially around a surface of the invertible prosthetic valvesupport that is initially an inner surface of the invertible prostheticvalve support. The invertible prosthetic valve support is anchored tothe native valve, and is subsequently inverted. Subsequent to theinversion of the invertible prosthetic valve support, the sealingelement is disposed on the outer surface of the invertible prostheticvalve support and acts to seal the interface between the outer surfaceand the native valve.

There is therefore provided, in accordance with some applications of thepresent invention, apparatus, including:

a prosthetic valve support configured to be placed at an annulus of anative atrioventricular valve of a patient, the prosthetic valve supportdefining an annular element that defines an inner cross-sectional areathereof;

an expandable prosthetic valve configured to be placed into a ventricleof the patient, the prosthetic valve including:

-   -   an expandable frame; and    -   prosthetic valve leaflets coupled to the expandable frame;

the expandable frame of the prosthetic valve being configured such thatwhen the frame is in a non-constrained state thereof, a cross-sectionalarea of the frame, along at least a given portion of a length of theframe, is greater than the cross-sectional area defined by the annularelement of the prosthetic valve support,

the prosthetic valve thereby being couplable to the prosthetic valvesupport at any location along the portion, responsively to radial forcesacted upon the valve support by the expandable frame, by the expandableframe being expanded when the location along the portion is aligned withthe annular element of the prosthetic valve support.

For some applications, the valve support is collapsible fortranscatheter delivery.

For some applications, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some applications, the annular element of the valve support isasymmetrically shaped.

For some applications, the annular element is shaped to define a hole,and a center of the hole is disposed asymmetrically with respect to anouter perimeter of the annular element.

For some applications, the frame includes proximally-facing protrusionsat a distal end thereof, the protrusions being configured to preventproximal migration of the valve into an atrium.

For some applications, the protrusions are disposed at an angle from theframe of more than 40 degrees.

For some applications, the protrusions are disposed at an angle from theframe of less than 80 degrees.

For some applications, a length of each of the protrusions is less than5 mm.

For some applications, the frame includes a single proximally-facingprotrusion corresponding to each native valve leaflet of the valve, eachof the protrusions having a width of less than 1 mm.

For some applications, the protrusions are disposed in a sinusoidalconfiguration such that the protrusions conform with a saddle shape ofthe patient's native annulus.

For some applications, the protrusions are configured to prevent thenative leaflets from interfering with a left ventricular outflow tractof the patient.

For some applications, the frame includes first and second sets of oneor more protrusions, each set of protrusions configured to ensnare arespective native leaflet of the native valve of the patient, the firstset of protrusions being disposed within a first circumferential arcwith respect to a longitudinal axis of the prosthetic valve, on a firstside of a distal end of the frame, the second set of protrusions beingdisposed within a second circumferential arc with respect to thelongitudinal axis of the prosthetic valve, on a second side of thedistal end of the frame, the first and second sets being disposed so asto provide first and second gaps therebetween at the distal end of theframe, at least one of the gaps having a circumferential arc of at least20 degrees, the apparatus further including one or more valve guidemembers configured to be delivered to one or more commissures of thenative valve, and to guide the valve such that the first and secondcircumferential arcs are aligned with respective leaflets of the nativevalve and such that the first and second gaps are aligned withrespective commissures of the native valve.

For some applications, the at least one of the gaps has acircumferential are of at least 60 degrees.

For some applications, the first circumferential arc defines an angle ofbetween 25 degrees and 90 degrees about the longitudinal axis of theprosthetic valve.

For some applications, the second circumferential arc defines an angleof between 25 degrees and 90 degrees about the longitudinal axis of theprosthetic valve.

For some applications, the first circumferential arc defines an angle ofbetween 45 degrees and 75 degrees about the longitudinal axis of theprosthetic valve.

For some applications, the second circumferential arc defines an angleof between 45 degrees and 75 degrees about the longitudinal axis of theprosthetic valve.

For some applications, the expandable frame of the prosthetic valve isconfigured such that when the frame is in a non-constrained statethereof the frame has a maximum diameter of less than 25 mm.

For some applications, the expandable frame of the prosthetic valve isconfigured such that when the frame is in a non-constrained statethereof the frame has a maximum diameter of more than 15 mm.

For some applications, the expandable frame of the prosthetic valve isconfigured such that when the frame is in a non-constrained statethereof the frame has a maximum diameter of less than 20 mm.

For some applications, the expandable frame of the prosthetic valve isconfigured such that when the frame is in a non-constrained statethereof, a cross-sectional area of the frame at a proximal end of theframe is greater than a cross-sectional area of the frame at a distalend of the frame.

For some applications, the expandable frame of the prosthetic valve isconfigured such that when the frame is in the non-constrained statethereof the frame defines a frustoconical shape.

For some applications, the expandable frame of the prosthetic valve isconfigured such that when the frame is in the non-constrained statethereof the frame defines a trumpet shape.

There is further provided, in accordance with some applications of thepresent invention, a method, including:

placing a prosthetic valve support at an annulus of a nativeatrioventricular valve of a patient, the prosthetic valve supportdefining an annular element that defines an inner cross-sectional areathereof;

placing into a ventricle of the patient, an expandable prosthetic valve,

-   -   the prosthetic valve including an expandable frame, and        prosthetic valve leaflets coupled to the expandable frame,    -   the expandable frame of the prosthetic valve being configured        such that when the frame is in a non-constrained state thereof,        a cross-sectional area of the frame, along at least a given        portion of a length of the frame, is greater than the        cross-sectional area defined by the annular element of the        prosthetic valve support;

determining a location anywhere along the portion at which to couple theexpandable valve the prosthetic valve support; and

in response thereto,

aligning the location along the portion of the expandable frame with theannular element of the prosthetic valve support; and

coupling the expandable valve to the prosthetic valve support at thelocation, responsively to radial forces acted upon the valve support bythe expandable frame, by facilitating expansion of the expandable frame,when the location along the portion is aligned with the annular elementof the prosthetic valve support.

For some applications, placing the valve support at the annulus includestranscatheterally placing the valve support at the annulus in acollapsed state.

For some applications, the native atrioventricular valve includes amitral valve, and placing the prosthetic valve into the ventricleincludes placing into the ventricle a prosthetic valve that includesthree prosthetic leaflets.

For some applications, placing the prosthetic valve support at theannulus includes placing an asymmetrically-shaped prosthetic valvesupport at the annulus.

For some applications, placing the prosthetic valve support at theannulus includes placing at the annulus an annular element that isshaped to define a hole, a center of the hole being disposedasymmetrically with respect to an outer perimeter of the annularelement, the annular element being placed such that a center of the holeis disposed asymmetrically with respect to the annulus.

For some applications, the frame includes proximally-facing protrusionsat a distal end thereof, the protrusions being configured to preventproximal migration of the valve into an atrium, and coupling theexpandable valve to the prosthetic valve support includes preventingproximal migration of the valve by coupling the valve to the valvesupport such that the leaflets are disposed at least partially betweenthe protrusions and the valve support.

For some applications, coupling the expandable valve to the prostheticvalve support includes preventing the native leaflets from interferingwith a left ventricular outflow tract of the patient.

For some applications, coupling the expandable valve to the prostheticvalve support includes allowing movement of the leaflets with respect tothe frame while preventing the proximal migration of the valve.

For some applications, the frame includes first and second sets of oneor more protrusions, each set of protrusions configured to ensnare arespective native leaflet of the native valve of the patient, the firstset of protrusions being disposed within a first circumferential arcwith respect to a longitudinal axis of the prosthetic valve, on a firstside of a distal end of the frame, the second set of protrusions beingdisposed within a second circumferential arc with respect to thelongitudinal axis of the prosthetic valve, on a second side of thedistal end of the frame, the first and second sets being disposed so asto provide first and second gaps therebetween at the distal end of theframe, at least one of the gaps having a circumferential arc of at least20 degrees, the method further including guiding the valve such that thefirst and second circumferential arcs are aligned with respectiveleaflets of the native valve and such that the first and second gaps arealigned with respective commissures of the native valve.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of less than25 mm.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of more than15 mm.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of less than20 mm.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame such that a cross-sectional area ofthe frame at a proximal end of the frame is greater than across-sectional area of the frame at a distal end of the frame.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame such that the frame defines afrustoconical shape.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame such that the frame defines atrumpet shape.

There is additionally provided, in accordance with some applications ofthe present invention, a method, including:

determining an indication of an area defined by an annulus of a nativeatrioventricular valve of a patient;

selecting a prosthetic valve support by determining that the prostheticvalve support defines an annular element that defines an innercross-sectional area that is less than the area defined by the annulus;

placing the prosthetic valve support at the annulus of the nativeatrioventricular valve;

placing into a ventricle of the patient, an expandable prosthetic valve,the prosthetic valve including an expandable frame, and prosthetic valveleaflets coupled to the expandable frame;

coupling the expandable valve to the prosthetic valve support at thelocation, responsively to radial forces acted upon the valve support bythe expandable frame, by facilitating expansion of the expandable frame,

a cross-sectional area defined by the expandable frame of the prostheticvalve being limited by the cross-sectional area defined by the annularelement of the prosthetic valve support, such as to facilitate sealingof the native valve with respect to the prosthetic valve by facilitatingclosing of leaflets of the native valve around the prosthetic valve,upon deployment of the prosthetic valve.

For some applications, facilitating closing of leaflets of the nativevalve around the prosthetic valve includes facilitating sealing of thenative valve at commissures of the native valve.

For some applications, facilitating closing of leaflets of the nativevalve around the prosthetic valve includes facilitating closing of theleaflets of the native valve around an outer surface of the expandableframe.

For some applications, placing the valve support at the annulus includestranscatheterally placing the valve support at the annulus in acollapsed state.

For some applications, the native atrioventricular valve includes amitral valve, and placing the prosthetic valve into the ventricleincludes placing into the ventricle a prosthetic valve that includesthree prosthetic leaflets.

For some applications, placing the prosthetic valve support at theannulus includes placing an asymmetrically-shaped prosthetic valvesupport at the annulus.

For some applications, placing the prosthetic valve support at theannulus includes placing at the annulus an annular element that isshaped to define a hole, a center of the hole being disposedasymmetrically with respect to an outer perimeter of the annularelement, the annular element being placed such that a center of the holeis disposed asymmetrically with respect to the annulus.

For some applications, the frame includes proximally-facing protrusionsat a distal end thereof, the protrusions being configured to preventproximal migration of the valve into an atrium, and coupling theexpandable valve to the prosthetic valve support includes preventingproximal migration of the valve by coupling the valve to the valvesupport such that the leaflets are disposed at least partially betweenthe protrusions and the valve support.

For some applications, coupling the expandable valve to the prostheticvalve support includes preventing the native leaflets from interferingwith a left ventricular outflow tract of the patient.

For some applications, coupling the expandable valve to the prostheticvalve support includes allowing movement of the leaflets with respect tothe frame while preventing proximal migration of the valve.

For some applications, the frame includes first and second sets of oneor more protrusions, each set of protrusions configured to ensnare arespective native leaflet of the native valve of the patient, the firstset of protrusions being disposed within a first circumferential arcwith respect to a longitudinal axis of the prosthetic valve, on a firstside of a distal end of the frame, the second set of protrusions beingdisposed within a second circumferential arc with respect to thelongitudinal axis of the prosthetic valve, on a second side of thedistal end of the frame, the first and second sets being disposed so asto provide first and second gaps therebetween at the distal end of theframe, at least one of the gaps having a circumferential arc of at least20 degrees, the method further including guiding the valve such that thefirst and second circumferential arcs are aligned with respectiveleaflets of the native valve and such that the first and second gaps arealigned with respective commissures of the native valve.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of less than25 mm.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of more than15 mm.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame to a maximum diameter of less than20 mm.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame such that a cross-sectional area ofthe frame at a proximal end of the frame is greater than across-sectional area of the frame at a distal end of the frame.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame such that the frame defines afrustoconical shape.

For some applications, facilitating expansion of the frame includesfacilitating expansion of the frame such that the frame defines atrumpet shape.

There is additionally provided, in accordance with some applications ofthe present invention, a method, including:

placing a prosthetic valve support at an annulus of a nativeatrioventricular valve of a patient;

placing a prosthetic valve into a ventricle of the patient, theprosthetic valve including protrusions at a distal end thereof;

ensnaring one or more native leaflets of the native valve of the patientwith the protrusions; and

coupling the prosthetic valve to the native valve,

-   -   by sandwiching native leaflets of the native valve between the        protrusions and the valve support, by pulling the prosthetic        valve proximally with respect to the valve support, and    -   while the native leaflets are sandwiched between the protrusions        and the valve support, coupling the prosthetic valve to the        valve support, by facilitating radial expansion of the        prosthetic valve such that the prosthetic valve is held in place        with respect to the valve support responsively to radial forces        acted upon the valve support by the prosthetic valve.

There is further provided, in accordance with some applications of thepresent invention, a method, including:

determining an indication of an area defined by an annulus of a nativeatrioventricular valve of a patient;

selecting a prosthetic valve to be placed in the native valve bydetermining that the valve defines a cross-sectional area that is lessthan 90% of the area defined by the annulus; and

deploying the prosthetic valve at the native valve,

the selecting of the prosthetic valve facilitating sealing of the nativevalve with respect to the prosthetic valve by facilitating closing ofleaflets of the native valve around the prosthetic valve, upondeployment of the prosthetic valve.

For some applications, selecting the prosthetic valve includes selectinga prosthetic valve having a material disposed on an outer surfacethereof.

For some applications, selecting the prosthetic valve includes selectinga prosthetic valve having a material that prevents tissue growthdisposed on an outer surface thereof.

For some applications, selecting the prosthetic valve includes selectinga prosthetic valve having a material that promotes tissue growthdisposed on an outer surface thereof.

For some applications, selecting the prosthetic valve to be placed inthe native valve includes determining that the valve defines across-sectional area that is less than 80% of the area defined by theannulus.

For some applications, selecting the prosthetic valve to be placed inthe native valve includes determining that the valve defines across-sectional area that is less than 60% of the area defined by theannulus.

There is further provided, in accordance with some applications of thepresent invention, apparatus, including:

one or more valve support guide members configured to be delivered toone or more commissures of a native atrioventricular valve of a patient;

one or more valve support anchors configured to be anchored to the oneor more commissures of the native valve;

a prosthetic valve support advanceable toward the native valve along theone or more valve support guide members and anchored to the native valveat at least the one or more commissures; and

a prosthetic valve configured to be coupled to the valve support.

For some applications, the valve support is collapsible fortranscatheter delivery and expandable to contact the nativeatrioventricular valve.

For some applications, the one or more valve support anchors areconfigured to be anchored to the one or more commissures fromventricular surfaces thereof.

For some applications, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some applications, the one or more valve support anchors includesfirst and second tissue anchors, the first and second tissue anchorsbeing configured to be anchored to respective first and secondcommissures of the atrioventricular valve of the patient.

For some applications:

the one or more valve support anchors each include one or moreradially-expandable prongs, and

the one or more prongs are disposed within a sheath in a compressedstate prior to the anchoring, and exposed from within the sheath inorder to expand and facilitate anchoring of the valve support anchor tothe respective commissures.

For some applications, the prosthetic valve includes two or moreprosthetic leaflets.

For some applications, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some applications, the valve support guide members are removablefrom the patient following the anchoring of the prosthetic valve supportat the atrioventricular valve.

For some applications, the valve support is shaped so as to define adistal portion which is configured to push aside, at least in part,native leaflets of the valve of the patient.

For some applications, the one or more valve support anchors areadvanceable along the one or more valve support guide members.

For some applications, the valve support is shaped so as to define oneor more holes, the one or more holes being configured to facilitateslidable passage therethrough of a respective one of the one or morevalve support guide members.

For some applications, the prosthetic valve is shaped so as to defineone or more snares configured to ensnare one or more native leaflets ofthe native valve of the patient.

For some applications, the one or more valve support anchors includesone or more ventricular anchors, and the apparatus further includes oneor more atrial anchors, each atrial anchor being configured to beadvanced toward an atrial surface of the valve support and anchor inplace the valve support in a vicinity of a respective one of theventricular anchors.

For some applications, the apparatus includes one or more deliverylumens, and:

each one of the one or more valve support anchors is removably coupledto a distal end of a respective delivery lumen,

the delivery lumen is configured to facilitate advancement of the one ormore anchors along the one or more guide members, and

the delivery lumen is decoupled from the anchor following the anchoringof the anchor to the one or more commissures.

For some applications, the one or more valve support guide members areremovable from the body of the patient following the advancement of theone or more anchors along the one or more guide members.

For some applications:

the valve support is shaped so as to define one or more holes,

the one or more holes are configured to facilitate slidable passagetherethrough of a respective one of the one or more delivery lumens, and

the one or more delivery lumens are decoupleable from the respectivevalve support anchor following the anchoring of the valve support to atleast the one or more commissures.

For some applications, the one or more delivery lumens are removablefrom the body of the patient following the anchoring of the valvesupport to at least the one or more commissures.

For some applications, the valve support includes an annular element anda generally cylindrical element coupled to the annular element, thegenerally cylindrical element being configured to push aside nativeleaflets of the native valve, the cylindrical element has first andsecond ends and a cylindrical body that is disposed between the firstand second ends.

For some applications, the apparatus includes one or more annularelement tissue anchors, the annular element has an upper surface and alower surface, and the lower surface is coupled to the one or moreannular element tissue anchors, the one or more annular element tissueanchors being configured to puncture tissue of a native annulus of thenative valve of the patient.

For some applications, one or more annular element tissue anchorsincludes a plurality of annular element tissue anchors positioned aroundthe lower surface of the annular element.

For some applications, the one or more annular element tissue anchorsincludes a first commissural anchor configured to puncture tissue of thenative valve at a first commissure thereof, and a second commissuralanchor configured to puncture tissue of the native valve at a secondcommissure thereof.

For some applications, each anchor of the one or more annular elementtissue anchors includes a distal pointed tip and one or moreradially-expandable prongs, the prongs being configured to expand andfacilitate anchoring of the anchor and restrict proximal motion of theannular element tissue anchor.

For some applications, the apparatus includes one or more prostheticvalve guide members reversibly couplable to the cylindrical element in avicinity of the second end of the cylindrical element, the prostheticvalve guide members being configured to facilitate advancement of theprosthetic valve therealong and toward the valve support.

For some applications:

-   -   the first end of the cylindrical element is coupled to the        annular element,    -   during a first period, the second end of the cylindrical element        is disposed above the annular element in a manner in which the        body of the cylindrical element is disposed above the annular        element, and    -   the cylindrical element is invertible in a manner in which,        during a second period, the second end of the cylindrical        element is disposed below the annular element and the body of        the cylindrical element is disposed below the annular element.

For some applications:

during the first period, the second end of the cylindrical element isdisposed in an atrium of a heart of the patient and the annular elementis positioned along an annulus of the native valve,

the prosthetic valve is advanceable along the one or more prostheticvalve guide members into a ventricle of the heart of the patient, and

in response to advancement of the prosthetic valve into the ventricle,the one or more prosthetic valve guide members are pulled into theventricle and pull the second end and the body of the cylindricalelement into the ventricle to invert the cylindrical element.

There is further provided, in accordance with some applications of thepresent invention, a method, including:

advancing one or more valve support guide members toward one or morecommissures of a native atrioventricular valve of a patient;

advancing along the one or more valve support guide members one or morevalve support tissue anchors toward the one or more commissures;

anchoring the one or more valve support tissue anchors to the one ormore commissures;

anchoring a prosthetic valve support at the native atrioventricularvalve by anchoring the prosthetic valve support at at least the one ormore commissures; and

coupling a prosthetic valve to the prosthetic valve support.

For some applications, the method includes removing the one or morevalve support guide members following the anchoring of the prostheticvalve support at the native atrioventricular valve.

For some applications, advancing the one or more valve support guidemembers toward the one or more commissures includes advancing one guidemember and looping the one guide member through first and secondcommissures of the native atrioventricular valve in a manner in which alooped portion of the guide member is disposed in a ventricle of thepatient and first and second free ends of the guide member areaccessible from a site outside a body of the patient.

For some applications, anchoring the one or more valve support anchorsincludes anchoring the one or more valve support anchors to ventricularsurface of the respective commissures of the native valve.

For some applications, anchoring the one or more valve support anchorsincludes anchoring first and second tissue anchors to respective firstand second commissures of the native valve.

For some applications:

advancing along the one or more valve support guide members the one ormore valve support tissue anchors includes advancing the one or morevalve support tissue anchors within a sheath, and

anchoring the one or more valve support tissue anchors includes exposingthe one or more valve support anchors from within the sheath andfacilitating radial expansion of one or more radially-expandable prongsof the one or more anchors.

For some applications, coupling the prosthetic valve to the prostheticvalve support includes coupling a prosthetic valve having two or moreleaflets.

For some applications, the native atrioventricular valve includes amitral valve of the patient, and coupling the prosthetic valve to theprosthetic valve support includes coupling a prosthetic valve havingthree leaflets.

For some applications, anchoring the prosthetic valve support includespushing aside, at least in part, native leaflets of the valve of thepatient by at least a portion of the support.

For some applications, the prosthetic valve support is coupled to one ormore annulus tissue anchors, and anchoring the prosthetic valve supportincludes pushing the one or more annulus tissue anchors into tissue ofan annulus of the native valve.

For some applications, coupling the prosthetic valve to the prostheticvalve support includes ensnaring one or more native leaflets of thenative valve of the patient by a portion of the prosthetic valve.

For some applications, the one or more valve support anchors includesone or more ventricular anchors, and the method further includesadvancing one or more atrial anchors to an atrial surface of the valvesupport, and anchoring in place the valve support in a vicinity of arespective one of the ventricular anchors.

For some applications, the method includes advancing the valve supportalong the one or more valve support guide members prior to the anchoringof the valve support.

For some applications, the valve support is shaped so as to define oneor more holes, and advancing the valve support along the one or morevalve support guide members includes threading the one or more valvesupport guide members through the one or more holes of the valve supportand sliding the valve support along the one or more guide members.

For some applications, the method includes removing the one or morevalve support guide members from a body of the patient following theanchoring of the valve support.

For some applications,

the valve support includes:

-   -   an annular element, and    -   a generally cylindrical element having first and second ends and        a cylindrical body that is disposed between the first and second        ends, the first end being coupled to the annular element; and

anchoring of the valve support, including anchoring the valve support ina manner in which:

-   -   the annular element is positioned along an annulus of the native        valve,    -   the second end of the cylindrical element is disposed above the        annular element in an atrium of a heart of the patient, and    -   the body of the cylindrical element is disposed above the        annular element.

For some applications, the method includes, following the anchoring,inverting the cylindrical element to pull the second end of thecylindrical element below the annular element and into a ventricle ofthe heart, in a manner in which the body of the cylindrical element isdisposed below the annular element and pushes aside one or more nativeleaflets of the valve of the patient.

For some applications:

inverting the cylindrical element includes advancing the prostheticvalve along one or more prosthetic valve guide members reversiblycoupled to the cylindrical element in a vicinity of the second endthereof,

advancing the prosthetic valve includes advancing the prosthetic valveinto the ventricle to pull the prosthetic valve guide members and thesecond end of the cylindrical element into the ventricle, and

the method further includes following the advancing of the prostheticvalve into the ventricle, pulling proximally the prosthetic valve suchthat a proximal portion of the valve contacts the valve support.

For some applications, pulling the prosthetic valve proximally includesensnaring the one or more leaflets of the valve by a portion of theprosthetic valve.

For some applications, advancing the one or more valve support anchorsincludes:

providing a respective delivery lumen coupled at a distal end thereof toeach one of the one or more anchors,

advancing each delivery lumen along a respective one of the one or morevalve support guide members,

facilitating anchoring of each one of the one or more anchors to the oneor more commissures by the respective delivery lumen, and

decoupling the delivery lumen from each one of the one or more valvesupport anchors following the anchoring of the one or more valve supportanchors.

For some applications, the method includes removing the one or morevalve support guide members from a body of the patient following theanchoring of each one of the one or more valve support anchors to theone or more commissures.

For some applications, the method includes advancing the prostheticvalve support along the one or more delivery lumens prior to theanchoring the support at the native atrioventricular valve.

For some applications, the valve support is shaped so as to define oneor more holes, and advancing the valve support along the one or moredelivery lumens includes threading the one or more delivery lumensthrough the one or more holes of the valve support and sliding the valvesupport along the one or more delivery lumens.

For some applications, the method includes removing the one or moredelivery lumens from a body of the patient following the anchoring thesupport at the atrioventricular valve.

There is additionally provided, in accordance with some applications ofthe present invention, apparatus including a valve support for receivinga prosthetic valve, the valve support including:

an annular element configured to be positioned along a native annulus ofa native atrioventricular valve of a patient; and

a flexible generally cylindrical element configured to be positioned inthe native atrioventricular valve of the patient and to push asidenative leaflets of the native valve, the cylindrical element havingfirst and second ends and a cylindrical body that is disposed betweenthe first and second ends, and:

-   -   the first end of the cylindrical element is coupled to the        annular element,    -   during a first period, the second end of the cylindrical element        is disposed above the annular element in a manner in which the        body of the cylindrical element is disposed above the annular        element, and    -   the cylindrical element is invertible in a manner in which,        during a second period, the second end of the cylindrical        element is disposed below the annular element and the body of        the cylindrical element is disposed below the annular element.

For some applications, the cylindrical element includes a flexiblewireframe covered by a fabric.

For some applications, the valve support is collapsible fortranscatheter delivery and expandable to contact the nativeatrioventricular valve.

For some applications, the annular element has an upper surface and alower surface, the lower surface is coupled to one or more annularelement tissue anchors configured to puncture tissue of the nativeannulus of the patient.

For some applications, the one or more annular element tissue anchorsincludes a plurality of annular element tissue anchors positioned aroundthe lower surface of the annular element.

For some applications, the one or more annular element tissue anchorsincludes a first commissural annular element tissue anchor configured topuncture tissue of the native valve at a first commissure thereof, and asecond commissural annular element tissue anchor configured to puncturetissue of the native valve at a second commissure thereof.

For some applications, each anchor of the one or more annular elementtissue anchors includes a distal pointed tip and one or moreradially-expandable prongs, the prongs being configured to expand andfacilitate anchoring of the anchor and restrict proximal motion of theannular element tissue anchor.

For some applications, the apparatus includes one or more valve supportguide members configured to be delivered to one or more commissures ofthe native atrioventricular valve of the patient, the one or more valvesupport guide members are configured to facilitate advancement of thevalve support toward the native valve.

For some applications, the valve support is shaped so as to define oneor more holes, the one or more holes configured to facilitate slidablepassage therethrough of a respective one of the one or more valvesupport guide members.

For some applications, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some applications, the apparatus includes one or more valve supporttissue anchors configured to be advanceable along the one or more valvesupport guide members and anchored to the one or more commissures of thevalve.

For some applications, the one or more valve support anchors includesone or more ventricular anchors, and the apparatus further includes oneor more atrial anchors, each atrial anchor being configured to beadvanced toward an atrial surface of the valve support and anchor inplace the valve support in a vicinity of a respective one of theventricular anchors.

For some applications, the valve support guide members are removablefrom the patient following the anchoring of the valve support at theatrioventricular valve.

For some applications, the one or more valve support anchors areconfigured to be anchored to the one or more commissures fromventricular surfaces thereof prior to advancement of the valve support.

For some applications, the one or more valve support tissue anchorsincludes first and second valve support tissue anchors, the first andsecond valve support tissue anchors being configured to be anchored torespective first and second commissures of the atrioventricular valve ofthe patient.

For some applications:

the one or more valve support tissue anchors each include one or moreradially-expandable prongs, and

the one or more prongs are disposed within a sheath in a compressedstate prior to the anchoring and exposed from within the sheath in orderto expand and facilitate anchoring of the anchor to the respectivecommissures.

For some applications, the apparatus includes one or more prostheticvalve guide members reversibly couplable to the cylindrical element in avicinity of the second end of the cylindrical element, the prostheticvalve guide members being configured to facilitate advancement of theprosthetic valve therealong and toward the valve support.

For some applications, the apparatus includes the prosthetic valve, andthe prosthetic valve is couplable to the valve support.

For some applications:

during the first period, the second end of the cylindrical element isdisposed in an atrium of a heart of the patient and the annular elementis positioned along an annulus of the native valve,

the prosthetic valve is advanceable along the one or more prostheticvalve guide members into a ventricle of the heart of the patient, and

in response to advancement of the prosthetic valve into the ventricle,the one or more prosthetic valve guide members are pulled into theventricle and pull the second end of the cylindrical element into theventricle to invert the cylindrical element.

For some applications, the prosthetic valve is collapsible fortranscatheter delivery and expandable when exposed from within adelivery catheter.

For some applications, the prosthetic valve includes two or moreprosthetic leaflets.

For some applications, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some applications, the prosthetic valve guide members are removablefrom the patient following the anchoring of the prosthetic valve at theatrioventricular valve.

For some applications, the prosthetic valve is shaped so as to defineone or more snares configured to ensnare one or more native leaflets ofthe native valve of the patient.

There is yet additionally provided, in accordance with some applicationsof the present invention, a method, including:

advancing toward a native atrioventricular valve of a heart of apatient, a valve support including:

-   -   an annular element, and    -   a generally cylindrical element having first and second ends and        a cylindrical body that is disposed between the first and second        ends, the first end being coupled to the annular element;

anchoring the annular element to an annulus of the nativeatrioventricular valve, following the anchoring, the second end of thecylindrical element is disposed above the annular element in an atriumof the heart, in a manner in which the body of the cylindrical elementis disposed above the annular element; and

following the anchoring, inverting the cylindrical element to pull thesecond end of the cylindrical element below the annular element and intoa ventricle of the heart, in a manner in which the body of thecylindrical element is disposed below the annular element and pushesaside one or more native leaflets of the valve of the patient.

For some applications, anchoring the annular element to the annulus ofthe native atrioventricular valve includes:

advancing one or more valve support anchors that are distinct from thevalve support toward one or more commissures of the heart, and

anchoring the annular element to the annulus using the one or morepositioning anchors.

For some applications, the annular element is coupled to one or moreannular element tissue anchors, and anchoring the annular elementincludes pushing the one or more annular element tissue anchors intotissue of the annulus.

For some applications:

inverting the cylindrical element includes advancing a prosthetic valvealong one or more valve guide members reversibly coupled to thecylindrical element in a vicinity of the second end thereof,

advancing the prosthetic valve includes advancing the prosthetic valveinto the ventricle to pull the guide members and the second end of thecylindrical element into the ventricle, and

the method further includes following the advancing of the prostheticvalve into the ventricle, pulling proximally the prosthetic valve suchthat a proximal portion of the valve contacts the valve support.

For some applications, pulling the prosthetic valve proximally includesensnaring the one or more leaflets of the valve by a portion of theprosthetic valve.

There is also provided, in accordance with some applications of thepresent invention, apparatus including a valve support for receiving aprosthetic valve, the valve support including:

an annular element configured to be positioned along a native annulus ofa native atrioventricular valve of a patient, the annular element havingupper and lower surfaces; and

one or more annular element tissue anchors coupled to the lower surfaceof the annular element, the one or more annular element tissue anchorsbeing configured to puncture tissue of the native annulus of thepatient.

For some applications, the valve support is collapsible fortranscatheter delivery and expandable to contact the nativeatrioventricular valve.

For some applications, the one or more annular element tissue anchorsincludes a plurality of annular element tissue anchors positioned aroundthe lower surface of the annular element.

For some applications, the one or more annular element tissue anchorsincludes a first commissural annular element tissue anchor configured topuncture tissue of the native valve at a first commissure thereof, and asecond commissural annular element tissue anchor configured to puncturetissue of the native valve at a second commissure thereof.

For some applications, each anchor of the one or more annular elementtissue anchors includes a distal pointed tip and one or moreradially-expandable prongs, the prongs being configured to expand andfacilitate anchoring of the anchor and restrict proximal motion of theanchor.

For some applications, the apparatus includes one or more valve supportguide members configured to be delivered to one or more commissures ofthe native atrioventricular valve of the patient, the one or more valvesupport guide members are configured to facilitate advancement of thevalve support toward the native valve.

For some applications, the valve support is shaped so as to define oneor more holes, the one or more holes configured to facilitate slidablepassage therethrough of a respective one of the one or more valvesupport guide members.

For some applications, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some applications, the apparatus includes one or more valve supporttissue anchors that are distinct from the valve support and areconfigured to be advanceable along the one or more valve support guidemembers and anchored to the one or more commissures of the valve.

For some applications, the one or more valve support anchors includesone or more ventricular anchors, and the apparatus further includes oneor more atrial anchors, each atrial anchor being configured to beadvanced toward an atrial surface of the valve support and anchor inplace the valve support in a vicinity of a respective one of theventricular anchors.

For some applications, the one or more valve support guide members areremovable from the patient following the anchoring of the valve supportat the atrioventricular valve.

For some applications, the one or more valve support tissue anchors areconfigured to be anchored to the one or more commissures fromventricular surfaces thereof prior to advancement of the valve support.

For some applications, the one or more valve support tissue anchorsincludes first and second valve support tissue anchors, the first andsecond valve support tissue anchors being configured to be anchored torespective first and second commissures of the atrioventricular valve ofthe patient.

For some applications:

the one or more valve support tissue anchors each include one or moreradially-expandable prongs, and

the one or more prongs are disposed within a sheath in a compressedstate prior to the anchoring and exposed from within the sheath in orderto expand and facilitate anchoring of the anchor to the respectivecommissures.

For some applications, the valve support further includes a flexiblegenerally cylindrical element coupled to the annular element andconfigured to be positioned in the native atrioventricular valve of thepatient and to push aside native leaflets of the native valve, thecylindrical element having first and second ends and a cylindrical bodythat is disposed between the first and second ends.

For some applications, the cylindrical element includes a flexiblewireframe covered by a fabric.

For some applications, the apparatus includes one or more prostheticvalve guide members reversibly couplable to the cylindrical element in avicinity of the second end of the cylindrical element, the prostheticvalve guide members being configured to facilitate advancement of theprosthetic valve therealong and toward the valve support.

For some applications, the apparatus includes the prosthetic valve, andthe prosthetic valve is couplable to the valve support.

For some applications:

-   -   the first end of the cylindrical element is coupled to the        annular element,    -   during a first period, the second end of the cylindrical element        is disposed above the annular element in a manner in which the        body of the cylindrical element is disposed above the annular        element, and    -   the cylindrical element is invertible in a manner in which,        during a second period, the second end of the cylindrical        element is disposed below the annular element and the body of        the cylindrical element is disposed below the annular element.

For some applications:

during the first period, the second end of the cylindrical element isdisposed in an atrium of a heart of the patient,

the prosthetic valve is advanceable along the one or more prostheticvalve guide members into a ventricle of the heart of the patient, and

in response to advancement of the prosthetic valve into the ventricle,the one or more prosthetic valve guide members are pulled into theventricle and pull the second end of the cylindrical element into theventricle to invert the cylindrical element.

There is additionally provided, in accordance with some applications ofthe present invention, apparatus, including:

one or more valve support guide members configured to be delivered toone or more commissures of a native atrioventricular valve of a patient;

a prosthetic valve support configured to be advanced toward the nativevalve along the one or more valve support guide members and placed atthe native valve;

a prosthetic valve configured to be coupled to the valve support; and

one or more sealing elements configured to facilitate sealing of aninterface between the prosthetic valve support and the native valve.

For some applications, the sealing element includes a balloon disposedcircumferentially around an outer surface of the prosthetic valvesupport.

For some applications, the sealing element includes one or more helicesthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by being wrapped around chordaetendineae of the native valve.

For some applications, the sealing element includes grasping elementsthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by grasping the commissures.

For some applications, the sealing element is configured to facilitateanchoring of the support to the native valve.

For some applications, the valve support is collapsible fortranscatheter delivery and expandable to contact the nativeatrioventricular valve.

For some applications, the prosthetic valve includes two or moreprosthetic leaflets.

For some applications, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some applications, the valve support guide members are removablefrom the patient following coupling of the prosthetic valve to the valvesupport.

For some applications, the valve support is shaped so as to define adistal portion which is configured to push aside, at least in part,native leaflets of the valve of the patient.

For some applications, the valve support is shaped so as to define oneor more holes, the one or more holes being configured to facilitateslidable passage therethrough of a respective one of the one or morevalve support guide members.

For some applications, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some applications, the apparatus further includes:

a guide wire configured to be advanced, via the native atrioventricularvalve, into a ventricle of the patient, and coupled to an inner wall ofthe patient's ventricle; and

a valve support guide member tube coupled to the guide wire,

and a distal portion of the valve support guide member is configured toloop through the valve support guide member tube, such that, in responseto the valve support guide member being pushed distally, portions of thevalve support guide member are pushed to respective commissures of thenative valve.

For some applications, the prosthetic valve is shaped so as to defineone or more protrusions configured to ensnare one or more nativeleaflets of the native valve of the patient.

For some applications, the protrusions are disposed in a sinusoidalconfiguration such that the protrusions conform with a saddle shape ofthe patient's native annulus.

For some applications, the protrusions are configured to prevent thenative leaflets from interfering with a left ventricular outflow tractof the patient, by sandwiching the leaflets between the protrusions andthe prosthetic valve support.

For some applications, the valve support includes:

a first end that is configured to be placed on an atrial side of anative atrioventricular valve of a patient; and

a second end that is configured, during a first period, to be disposedinside the patient's atrium, above the first end of the valve support,

the valve support being at least partially invertible in a manner inwhich, during a second period, the second end of the valve support isdisposed at least partially inside a ventricle of the patient, below thefirst end of the valve support.

For some applications, the valve support includes an annular element anda generally cylindrical element coupled to the annular element, thegenerally cylindrical element being configured to push aside nativeleaflets of the native valve, and the cylindrical element has first andsecond ends and a cylindrical body that is disposed between the firstand second ends.

For some applications, the sealing element includes a balloon disposedunderneath the annular element and configured to facilitate sealing ofan interface between the annular element and the native valve.

For some applications, the apparatus further includes one or moreprosthetic valve guide members, the prosthetic valve guide members beingconfigured to facilitate advancement of the prosthetic valve therealongand toward the valve support.

For some applications:

the first end of the cylindrical element is coupled to the annularelement,

during a first period, the second end of the cylindrical element isdisposed above the annular element in a manner in which the body of thecylindrical element is disposed above the annular element, and

the cylindrical element is invertible in a manner in which, during asecond period, the second end of the cylindrical element is disposedbelow the annular element and the body of the cylindrical element isdisposed below the annular element.

For some applications:

during the first period, the second end of the cylindrical element isdisposed in an atrium of a heart of the patient and the annular elementis positioned along an annulus of the native valve,

the prosthetic valve is advanceable along the one or more prostheticvalve guide members into a ventricle of the heart of the patient, and

in response to advancement of the prosthetic valve into the ventricle,the one or more prosthetic valve guide members are pulled into theventricle and pull the second end and the body of the cylindricalelement into the ventricle to invert the cylindrical element.

There is further provided, in accordance with some applications of thepresent invention, apparatus, including:

a prosthetic valve support configured to be advanced toward a nativeatrioventricular valve of a patient and placed at the native valve;

a prosthetic valve configured to be coupled to the valve support, theprosthetic valve being shaped so as to define first and second sets ofone or more protrusions, each set of protrusions configured to ensnare arespective native leaflet of the native valve of the patient, the firstset of protrusions being disposed within a first circumferential arcwith respect to a longitudinal axis of the prosthetic valve, on a firstside of a distal end of the prosthetic valve, the second set ofprotrusions being disposed within a second circumferential arc withrespect to the longitudinal axis of the prosthetic valve, on a secondside of the distal end of the prosthetic valve, the first and secondsets being disposed so as to provide first and second gaps therebetweenat the distal end of the prosthetic valve, at least one of the gapshaving a circumferential arc of at least 20 degrees; and

one or more valve guide members configured to be delivered to one ormore commissures of the native valve, and to guide the valve such thatthe first and second circumferential arcs are aligned with respectiveleaflets of the native valve and such that the first and second gaps arealigned with respective commissures of the native valve.

For some applications, the at least one of the gaps has acircumferential arc of at least 60 degrees.

For some applications, the first circumferential arc defines an angle ofbetween 25 degrees and 90 degrees about the longitudinal axis of theprosthetic valve.

For some applications, the second circumferential arc defines an angleof between 25 degrees and 90 degrees about the longitudinal axis of theprosthetic valve.

For some applications, the first circumferential arc defines an angle ofbetween 45 degrees and 75 degrees about the longitudinal axis of theprosthetic valve.

For some applications, the second circumferential arc defines an angleof between 45 degrees and 75 degrees about the longitudinal axis of theprosthetic valve.

There is additionally provided, in accordance with some applications ofthe present invention, a method, including:

determining an area defined by an annulus of a native atrioventricularvalve of a patient;

selecting a prosthetic valve to be placed in the native valve bydetermining that the valve defines a cross-sectional area that is lessthan 90% of the area defined by the annulus; and

deploying the prosthetic valve at the native valve,

the selecting of the prosthetic valve facilitating sealing of the nativevalve with respect to the prosthetic valve by facilitating closing ofleaflets of the native valve around the prosthetic valve, upondeployment of the prosthetic valve.

For some applications, selecting the prosthetic valve includes selectinga prosthetic valve having a material disposed on an outer surfacethereof.

For some applications, selecting the prosthetic valve includes selectinga prosthetic valve having a material that prevents tissue growthdisposed on an outer surface thereof.

For some applications, selecting the prosthetic valve includes selectinga prosthetic valve having a material that promotes tissue growthdisposed on an outer surface thereof.

For some applications, selecting the prosthetic valve to be placed inthe native valve includes determining that the valve defines across-sectional area that is less than 80% of the area defined by theannulus.

For some applications, selecting the prosthetic valve to be placed inthe native valve includes determining that the valve defines across-sectional area that is less than 60% of the area defined by theannulus.

There is further provided, in accordance with some applications of thepresent invention, apparatus including:

a valve support for receiving a prosthetic valve, the valve supportincluding:

-   -   a first end that is configured to be placed on an atrial side of        a native atrioventricular valve of a patient; and    -   a second end that is configured, during a first period, to be        disposed inside the patient's atrium, above the first end of the        valve support,    -   the valve support being at least partially invertible in a        manner in which, during a second period, the second end of the        cylindrical element is disposed at least partially inside a        ventricle of the patient, below the first end of the valve        support.

For some applications, the valve support includes a flexible wireframecovered by a fabric.

For some applications, the valve support is collapsible fortranscatheter delivery and expandable to contact the nativeatrioventricular valve.

For some applications, the valve support defines a surface that is aninner surface of the valve support during the first period, and an outersurface of the valve support during the second period, and the apparatusfurther includes a sealing material that is disposed on the surface,such that during the second period the sealing material facilitatessealing between the valve support and the native valve.

For some applications, the first end includes a coupling elementconfigured to couple the valve support to tissue of the native valve onthe atrial side of the native valve.

For some applications, the first end is shaped to define barbs that areconfigured to couple the valve support to tissue of the native valve onthe atrial side of the native valve

For some applications, the valve support includes:

an annular element configured to be positioned along a native annulus ofthe native atrioventricular valve; and

a flexible generally cylindrical element configured to be positioned inthe native atrioventricular valve of the patient and to push asidenative leaflets of the native valve, the first end of the cylindricalelement defining the first end of the valve support, and the first endof the cylindrical element being coupled to the annular element.

For some applications, the apparatus further includes one or more valvesupport guide members configured to be delivered to one or morecommissures of the native atrioventricular valve of the patient, and theone or more valve support guide members are configured to facilitateadvancement of the valve support toward the native valve.

For some applications, the valve support is shaped so as to define oneor more holes, the one or more holes configured to facilitate slidablepassage therethrough of a respective one of the one or more valvesupport guide members.

For some applications, the one or more valve support guide membersincludes one valve support guide member that is looped through first andsecond commissures of the atrioventricular valve in a manner in which alooped portion of the valve support guide member is disposed in aventricle of the patient and first and second free ends of the valvesupport guide member are accessible from a site outside a body of thepatient.

For some applications, the apparatus further includes:

a guide wire configured to be advanced, via the native atrioventricularvalve, into a ventricle of the patient, and coupled to an inner wall ofthe patient's ventricle; and

a valve support guide member tube coupled to the guide wire,

and a distal portion of the valve support guide member is configured toloop through the valve support guide member tube, such that, in responseto the valve support guide member being pushed distally, portions of thevalve support guide member are pushed to respective commissures of thenative valve.

For some applications, the apparatus further includes one or moreprosthetic valve guide members reversibly couplable to the cylindricalelement in a vicinity of the second end of the cylindrical element, theprosthetic valve guide members being configured to facilitateadvancement of the prosthetic valve therealong and toward the valvesupport.

For some applications, the apparatus further includes the prostheticvalve, and the prosthetic valve is couplable to the valve support.

For some applications:

during the first period, the second end of the cylindrical element isdisposed in an atrium of a heart of the patient and the annular elementis positioned along an annulus of the native valve,

the prosthetic valve is advanceable along the one or more prostheticvalve guide members into a ventricle of the heart of the patient, and

in response to advancement of the prosthetic valve into the ventricle,the one or more prosthetic valve guide members are pulled into theventricle and pull the second end of the cylindrical element into theventricle to invert the cylindrical element.

For some applications, the apparatus further includes one or moresealing elements configured to facilitate sealing of an interfacebetween the prosthetic valve support and the native valve.

For some applications, the sealing element includes a balloon disposedcircumferentially around a surface of the prosthetic valve support.

For some applications, the sealing element includes one or more helicesthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by being wrapped around chordaetendineae of the native valve.

For some applications, the sealing element includes grasping elementsthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by grasping the commissures.

For some applications, the sealing element is configured to facilitateanchoring of the support to the native valve.

For some applications, the apparatus further includes the prostheticvalve, and the prosthetic valve is couplable to the valve support.

For some applications, the prosthetic valve is collapsible fortranscatheter delivery and expandable when exposed from within adelivery catheter.

For some applications, the prosthetic valve includes two or moreprosthetic leaflets.

For some applications, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some applications, the prosthetic valve is shaped so as to defineone or more protrusions configured to ensnare one or more nativeleaflets of the native valve of the patient.

For some applications, the protrusions are disposed in a sinusoidalconfiguration such that the protrusions conform with a saddle shape ofthe patient's native annulus.

For some applications, the protrusions are configured to prevent thenative leaflets from interfering with a left ventricular outflow tractof the patient, by sandwiching the leaflets between the protrusions andthe prosthetic valve support.

There is further provided, in accordance with some applications of thepresent invention, apparatus, including:

a guide wire configured to be advanced into a patient's ventricle via anative atrioventricular valve of the patient, and coupled to an innerwall of the patient's ventricle;

a valve support guide member tube coupled to the guide wire;

a valve support guide member, a distal portion of the valve supportguide member looping through the valve support guide member tube, suchthat, in response to the valve support guide member being pusheddistally, portions of the valve support guide member are pushed torespective commissures of the native valve;

a prosthetic valve support configured to be advanced toward thecommissures of the native valve along the valve support guide memberportions; and

a prosthetic valve configured to be coupled to the valve support.

For some applications, first and second free ends of the valve supportguide member are accessible from a site outside a body of the patient.

For some applications, the valve support includes:

an annular element configured to be positioned along a native annulus ofthe native atrioventricular valve; and

a generally cylindrical element configured to be positioned in thenative atrioventricular valve of the patient and to push aside nativeleaflets of the native valve, the cylindrical element being coupled tothe annular element, at a first end of the cylindrical element.

For some applications, the valve support is shaped so as to define oneor more holes, the one or more holes configured to facilitate slidablepassage therethrough of respective portions of the portions of the valvesupport guide member.

For some applications, the guide member is configured to facilitateadvancement of the prosthetic valve therealong and toward the valvesupport.

For some applications, the prosthetic valve is collapsible fortranscatheter delivery and expandable when exposed from within adelivery catheter.

For some applications, the prosthetic valve includes two or moreprosthetic leaflets.

For some applications, the native atrioventricular valve includes amitral valve, and the prosthetic valve includes three prostheticleaflets.

For some applications, the guide member is removable from the patientfollowing the coupling of the prosthetic valve to the valve support.

For some applications, the prosthetic valve is shaped so as to defineone or more protrusions configured to ensnare one or more nativeleaflets of the native valve of the patient.

For some applications, the protrusions are disposed in a sinusoidalconfiguration such that the protrusions conform with a saddle shape ofthe patient's native annulus.

For some applications, the protrusions are configured to prevent thenative leaflets from interfering with a left ventricular outflow tractof the patient, by sandwiching the leaflets between the protrusions andthe prosthetic valve support.

For some applications, the apparatus further includes one or moresealing elements configured to facilitate sealing of an interfacebetween the prosthetic valve support and the native valve.

For some applications, the sealing element includes a balloon disposedcircumferentially around a surface of the prosthetic valve support.

For some applications, the sealing element includes one or more helicesthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by being wrapped around chordaetendineae of the native valve.

For some applications, the sealing element includes grasping elementsthat are configured to facilitate sealing of commissures of the nativevalve with respect to the valve support by grasping the commissures.

For some applications, the sealing element is configured to facilitateanchoring of the support to the native valve.

There is additionally provided, in accordance with some applications ofthe present invention, apparatus, including:

one or more valve guide members configured to be delivered to one ormore commissures of a native atrioventricular valve of a patient;

a prosthetic valve configured to be advanced to be advanced toward thenative valve along the one or more valve guide members and placed at thenative valve at at least the one or more commissures; and

one or more proximally-facing grasping elements that are configured tofacilitate sealing of commissures of the native valve with respect tothe valve by:

-   -   being inserted into a ventricle of the patient; and    -   being pulled proximally and being closed around tissue in a        vicinity of the commissures.

For some applications, the grasping elements include two surfaces thatare hingedly coupled to one another, and that are configured tofacilitate the sealing of the commissures of the native valve withrespect to the prosthetic valve by being closed about the hinge withrespect to one another.

There is further provided, in accordance with some applications of thepresent invention, a method, including:

advancing one or more valve support guide members toward one or morecommissures of a native atrioventricular valve of a patient;

placing a prosthetic valve support at the native atrioventricular valveby advancing the valve support along the one or more valve support guidemembers;

coupling a prosthetic valve to the prosthetic valve support; and

facilitating sealing of an interface between the prosthetic valvesupport and the native valve by deploying a sealing element in avicinity of the interface.

There is additionally provided, in accordance with some applications ofthe present invention, a method including:

placing a first end of a prosthetic valve support on an atrial side of anative atrioventricular valve of a patient, such that a second end ofthe valve support is disposed, during a first period, inside thepatient's atrium, above the first end of the valve support; and

subsequent to the placing of the valve support, inverting at least aportion of the valve support such that, during a second period, thesecond end of the valve support is disposed at least partially inside aventricle of the patient, below the first end of the valve support.

There is additionally provided, in accordance with some applications ofthe present invention, a method, including:

advancing a guide wire, via a native atrioventricular valve, into aventricle of the patient, a valve support guide member tube beingcoupled to the guide wire;

coupling a distal end of the guide wire to an inner wall of thepatient's ventricle; and

causing portions of a valve support guide member to be pushed torespective commissures of the native valve, by pushing the guide memberdistally, a distal portion of the valve support guide member loopingthrough the valve support guide member tube;

advancing a prosthetic valve support toward the commissures of thenative valve along the valve support guide member portions; and

coupling a prosthetic valve to the valve support.

There is further provided, in accordance with some applications of thepresent invention, a method, including:

advancing one or more valve guide members toward one or more commissuresof a native atrioventricular valve of a patient;

placing a prosthetic valve at the native atrioventricular valve byadvancing the valve along the one or more valve guide members; and

facilitating sealing of commissures of the native valve with respect tothe valve by:

-   -   inserting into a ventricle of the patient one or more grasping        elements that are coupled to the prosthetic valve;    -   pulling the grasping elements proximally; and    -   closing the grasping elements around tissue in a vicinity of the        commissures.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-B are schematic illustrations of advancement of one or moreguide members toward respective commissures of a mitral valve, inaccordance with some applications of the present invention;

FIGS. 1C-D are schematic illustrations of the advancement and deploymentof commissural anchors via the guide members, in accordance with someapplications of the present invention;

FIGS. 2A-D are schematic illustrations of the advancement of aprosthetic valve support toward a native atrioventricular valve of apatient, in accordance with some applications of the present invention;

FIGS. 2E-F are schematic illustrations of locking of the prostheticvalve support at the native valve, in accordance with some applicationsof the present invention;

FIGS. 2G-K are schematic illustrations of the advancement of aprosthetic valve and the coupling of the prosthetic valve to the valvesupport, in accordance with some applications of the present invention;

FIGS. 3A-B are schematic illustrations of the advancement of aprosthetic valve support toward a native atrioventricular valve of apatient, the valve support including a sealing balloon, in accordancewith some applications of the present invention;

FIGS. 3C-D are schematic illustrations of locking of the prostheticvalve support at the native valve, the valve support including thesealing balloon, in accordance with some applications of the presentinvention;

FIGS. 4A-C are schematic illustrations of a valve support being usedwith commissural helices that facilitate anchoring and/or sealing of thevalve support, in accordance with some applications of the presentinvention;

FIGS. 5A-D are schematic illustrations of grasping elements being usedto anchor and/or provide sealing of a prosthetic valve, in accordancewith some applications of the present invention;

FIGS. 6A-B are schematic illustrations of a prosthetic valve thatincludes a sealing material, in accordance with some applications of thepresent invention;

FIGS. 7A-F are schematic illustrations of a guide wire delivery system,in accordance with some applications of the present invention;

FIGS. 8A-C are schematic illustrations of a valve support that has acylindrical element that is invertible, in accordance with someapplications of the present invention;

FIGS. 9A-D are schematic illustrations of the advancement of aninvertible prosthetic valve support toward a native atrioventricularvalve of a patient, in accordance with some applications of the presentinvention;

FIG. 9E is a schematic illustration of inversion of the invertibleprosthetic valve support at the native valve, in accordance with someapplications of the present invention;

FIGS. 9F-H are schematic illustrations of the advancement of aprosthetic valve and the coupling of the prosthetic valve to theinvertible valve support, in accordance with some applications of thepresent invention;

FIG. 10 is a schematic illustration of a prosthetic valve, thecross-sectional area of which is smaller than the area defined by thepatient's native valve annulus, in accordance with some applications ofthe present invention;

FIGS. 11A-D are schematic illustrations of a prosthetic valve thatdefines protrusions from portions of the distal end of the valve, inaccordance with some applications of the present invention;

FIGS. 12A-C are schematic illustrations of a prosthetic valve thatdefines distal protrusions that are disposed sinusoidally around thecircumference of the valve, in accordance with some applications of thepresent invention;

FIGS. 13A-E are schematic illustrations of respective configurations ofa frame of a prosthetic valve, in accordance with some applications ofthe present invention;

FIGS. 14A-D are schematic illustrations of respective configurations ofa prosthetic valve support, in accordance with some applications of thepresent invention;

FIGS. 15A-E are schematic illustrations of respective steps of aprocedure for deploying a prosthetic valve, in accordance with someapplications of the present invention;

FIGS. 16A-H are schematic illustrations of respective steps of analternative procedure for deploying a prosthetic valve, in accordancewith some applications of the present invention;

FIGS. 17A-C are schematic illustrations of leaflets of a prostheticvalve, in accordance with some applications of the present invention;

FIGS. 18A-B are schematic illustrations of a valve support coupled to aplurality of tissue anchors, in accordance with some applications of thepresent invention;

FIGS. 19A-D are schematic illustrations of the valve support of FIGS.18A-B being implanted in the native valve of the patient andfacilitating implantation of a prosthetic valve, in accordance with someapplications of the present invention; and

FIGS. 20A-B are schematic illustrations of a prosthetic valve and aprosthetic valve support deployed, respectively, at a tricuspid valve,and at an aortic valve, in accordance with some applications of thepresent invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Reference is now made to FIGS. 1A-B, which are schematic illustrationsof a system 20 for replacing an atrioventricular valve 5 of a patientcomprising one or more guide members 21 a and 21 b which are advancedtoward first and second commissures 8 and 10 of valve 5 of a heart 2 ofthe patient, in accordance with some applications of the presentinvention. For some applications, guide members 21 a and 21 b comprisedistinct guide members. Alternatively (as shown in FIGS. 7A-F), only oneguide member is looped through commissures 8 and 10 in a manner in whichthe guide member defines a looped portion between commissures 8 and 10(i.e., a portion of the guide member that is disposed in a ventricle 6of heart 2), and first and second free ends which are disposed andaccessible at a site outside the body of the patient. For suchapplications, the guide member defines portions 21 a and 21 b.

It is noted that for applications in which valve 5 is the patient'smitral valve, first and second commissures 8 and 10 are the anterior andposterior commissures. For applications in which valve 5 is thepatient's tricuspid valve (which includes three commissures), the firstand second commissures are typically the anterior and posteriorcommissures of the tricuspid valve.

For some applications, guide members 21 a and 21 b comprise guide wireshaving a diameter of 0.035 inches.

The transcatheter procedure typically begins with the advancing of asemi-rigid guide wire into a right atrium 4 of the patient. Thesemi-rigid guide wire provides a guide for the subsequent advancement ofa sheath 25 therealong and into the right atrium. Once sheath 25 hasentered the right atrium, the semi-rigid guide wire is retracted fromthe patient's body. Sheath 25 typically comprises a 13-20 F sheath,although the size may be selected as appropriate for a given patient.Sheath 25 is advanced through vasculature into the right atrium using asuitable point of origin typically determined for a given patient. Forexample:

-   -   sheath 25 may be introduced into the femoral vein of the        patient, through an inferior vena cava, into the right atrium,        and into the left atrium transseptally, typically through the        fossa ovalis;    -   sheath 25 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into the right        atrium, and into the left atrium transseptally, typically        through the fossa ovalis; or    -   sheath 25 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into the        right atrium, and into the left atrium transseptally, typically        through the fossa ovalis.

In some applications of the present invention, sheath 25 is advancedthrough the inferior vena cava of the patient and into the right atriumusing a suitable point of origin typically determined for a givenpatient.

Sheath 25 is advanced distally until sheath 25 reaches the interatrialseptum. For some applications, a resilient needle and a dilator (notshown) are advanced through the sheath and into the heart. In order toadvance the sheath transseptally into the left atrium, the dilator isadvanced to the septum, and the needle is pushed from within the dilatorand is allowed to puncture the septum to create an opening thatfacilitates passage of the dilator and subsequently the sheaththerethrough and into the left atrium. The dilator is passed through thehole in the septum created by the needle. Typically, the dilator isshaped to define a hollow shaft for passage along the needle, and thehollow shaft is shaped to define a tapered distal end. This tapereddistal end is first advanced through the hole created by the needle. Thehole is enlarged when the gradually increasing diameter of the distalend of the dilator is pushed through the hole in the septum.

The advancement of sheath 25 through the septum and into the left atriumis followed by the extraction of the dilator and the needle from withinsheath 25.

FIGS. 1C-D and 2A-B show advancement of one or more tissue anchors 30 aand 30 b along guide members 21 a and 21 b, respectively. Anchors 30 aand 30 b comprise a flexible, biocompatible material (e.g., nitinol) andcomprise one or more (e.g., a plurality of) radially-expandable prongs32 (e.g., barbs). Each anchor 30 a and 30 b is reversibly coupled to arespective delivery lumen 27 a and 27 b. Each delivery lumen 27 slidesaround a respective guide member 21. A respective surrounding sheath 26a and 26 b surrounds each delivery lumen 27 a and 27 b and aroundanchors 30 a and 30 b at least in part in order to compress and preventexpansion of prongs 32 of tissue anchors 30 a and 30 b.

As shown in FIG. 1D, the distal ends of lumens 27 a and 27 b arereversibly coupled to ribbed crimping structures 34. As describedhereinbelow, anchors 30 a and 30 b are anchored to ventricular surfacesof commissures 8 and 10. Following the anchoring, ribbed crimpingstructures 34 extend from anchors 30 a and 30 b through commissures 8and 10, respectively, and toward the atrial surfaces of commissures 8and 10. Ribbed crimping structures 34 are configured to facilitateanchoring of a valve support (described hereinbelow) to the atrialsurfaces of commissures 8 and 10.

Anchors 30 a and 30 b, ribbed crimping structures 34, and the distalends of surrounding sheaths 26 a and 26 b are advanced into ventricle 6.Subsequently, anchors 30 a and 30 b are pushed distally from withinsheaths 26 a and 26 b, (or sheaths 26 a and 26 b are pulled proximallywith respect to anchors 30 a and 30 b) to expose anchors 30 a and 30 b.As anchors 30 a and 30 b are exposed from within sheaths 26 a and 26 b,prongs 32 are free to expand, as shown in FIG. 1D. Prongs 32 expand suchthat anchors 30 a and 30 b assume a flower shape. Prongs 32,collectively in their expanded state, create a larger surface area toengage tissue than in their compressed states. Following the exposing ofanchors 30 a and 30 b, sheaths 26 a and 26 b are extracted.

As shown in FIG. 2B, lumens 27 a and 27 b are pulled proximally so thatprongs 32 of anchors 30 a and 30 b engage respective ventricular surfaceof commissures 8 and 10. Prongs 32 create a large surface area whichrestricts proximal motion of anchors 30 a and 30 b from commissures 8and 10, respectively.

For some applications, following the anchoring of anchors 30 a and 30 bto commissures 8 and 10, respectively, guide members 21 a and 21 b areremoved from the body of the patient.

Reference is now made to FIGS. 2C-F, which are schematic illustrationsof the advancement of a prosthetic valve support 40 along lumens 27 aand 27 b, in accordance with some applications of the present invention.In such a manner, lumens 27 a and 27 b function as valve support guidemembers. Support 40 comprises a collapsible skirt having a proximalannular element 44 and a distal cylindrical element 42. Support 40 isconfigured to assume a collapsed state (e.g., surrounded by a sheath orovertube 50 shown in FIG. 2C) for minimally-invasive delivery to thediseased native valve, such as by percutaneous or transluminal deliveryusing one or more catheters. FIG. 2C and the other figures show support40 in an expanded state after delivery in right atrium 4 and advancementtoward the native valve. As shown in FIG. 2D, support 40 is shaped so asto define one or more (e.g., two, as shown in View A) holes 46 a and 46b for slidable advancement of support 40 along lumens 27 a and 27 b,respectively. That is, prior to introduction of support 40 into the bodyof the patient, lumens 27 a and 27 b are threaded through holes 46 a and46 b, respectively, and support 40 is slid along lumens 27 a and 27 b.Support 40 is slid by pushing elements 52 a and 52 b which surrounddelivery lumens 27 a and 27 b, respectively.

It is to be noted that support 40 is slid along lumens 27 a and 27 b byway of illustration and not limitation. That is, for some applications,following the anchoring of anchors 30 a and 30 b to commissures 8 and10, respectively, guide members 21 a and 21 b are not removed from thebody of the patient, but rather lumens 27 a and 27 b are removed (e.g.,by being decoupled from crimping structures 34) leaving behind anchors30 a and 30 b and guide members 21 a and 21 b. Guide members 21 a and 21b may then be threaded through holes 46 a and 46 b, respectively, andsupport 40 is slid along guide members 21 a and 21 b. In such a manner,guide members 21 a and 21 b function as valve support guide members.

Support 40 comprises a collapsible flexible support frame 48, which isat least partially covered by a covering 49. Support 40 is configured tobe placed at native valve 5, such that cylindrical element 42 passesthrough the orifice of the native valve and extends towards, and,typically partially into, ventricle 6 (as shown in FIG. 2E). Cylindricalelement 42 typically pushes aside and presses against native leaflets ofnative valve 5 at least in part, which are left in place during andafter implantation of the prosthetic valve. Annular element 44 isconfigured to be placed around a native annulus 11 of the native valve,and to extend at least partially into an atrium 4 such that annularelement 44 rests against the native annulus. Annular element 44 istypically too large to pass through the annulus, and may, for example,have an outer diameter of between 30 and 60 mm.

For some applications, collapsible support frame 48 comprises a stent,which comprises a plurality of struts. The struts may comprise, forexample, a metal such as nitinol or stainless steel. For someapplications, frame 48 comprises a flexible metal, e.g., nitinol, whichfacilitates compression of support 40 within a delivery sheath orovertube 50. For some applications, covering 49 comprises a fabric, suchas a woven fabric, e.g., Dacron. Covering 49 is typically configured tocover at least a portion of cylindrical element 42, and at least aportion of annular element 44. The covering may comprise a single piece,or a plurality of pieces sewn together.

As shown in FIG. 20 , pushing elements 52 a and 52 b are each coupled tolocking crimping elements 64 a and 64 b, respectively. Locking crimpingelements 64 a and 64 b are disposed adjacently, proximally to holes 46 aand 46 b respectively of valve support 40. These techniques enable thesurgeon to readily bring crimping elements 64 a and 64 b to theappropriate sites along annular element 44, without the need forexcessive imaging, such as fluoroscopy.

FIG. 2E shows valve support 40 prior to implantation at annulus 11. Asshown, ribbed crimping structures 34 project away from anchors 30 a and30 b, through commissures 8 and 10, and toward atrium 4. Valve support40 is advanced along lumens 27 a and 27 b toward structures 34 by beingpushed by pushing elements 52 a and 52 b and locking crimping elements64 a and 64 b.

In FIG. 2F, valve support 40 is further pushed by pushing elements 52 aand 52 b and locking crimping elements 64 a and 64 b such holes 46 a and46 b of support 40 advance around ribbed crimping structures 34. Asholes 46 a and 46 b are advanced around ribbed crimping structures 34,locking crimping elements 64 a and 64 b advance over and surround ribbedcrimping elements 34 to lock in place valve support 40 from an atrialsurface of valve 5.

Responsively to the placement of valve support 40 at native valve 5,cylindrical element 42 is positioned partially within ventricle 6 andnative leaflets 12 and 14 of native valve 5 are pushed aside.

As shown in section A-A, ribbed crimping structures 34 are shaped so asto define a plurality of male couplings. Locking crimping elements 64 aand 64 b each comprise a cylindrical element having an inner lumen thatis shaped so as to surround a respective ribbed crimping structure 34.Each inner lumen of locking crimping elements 64 a and 64 b is shaped soas to define female couplings to receive the male couplings of ribbedcrimping structure 34. The female couplings of locking crimping element64 are directioned such that they facilitate distal advancement oflocking crimping element 64 while restricting proximal advancement oflocking crimping element 64. When the female couplings of lockingcrimping element 64 receive the male couplings of ribbed crimpingstructure 34, valve support 40 is locked in place from an atrial surfaceof valve 5. It is to be noted that for some applications, ribbedcrimping elements 34 comprise female couplings, and locking crimpingelements 64 comprise male couplings.

Reference is now made to FIGS. 2G-K which are schematic illustrations ofthe coupling of a prosthetic atrioventricular valve 80 to valve support40, in accordance with some applications of the present invention.Support 40 receives the prosthetic valve and functions as a dockingstation. Thus, the docking station is a coupling element that providescoupling between two other elements (in this case, between annulus 11and the prosthetic valve.)

Following the placement of support 40 at annulus 11, pushing elements 52a and 52 b and sheath or overtube 50 are removed from the body of thepatient, leaving behind lumens 27 a and 27 b, as shown in FIG. 2G.

As shown in FIG. 2G, a guide wire 72 is advanced toward ventricle 6 andfacilitates the advancement of an overtube 70 through sheath 25 and thepositioning of a distal end of overtube 70 within ventricle 6. Overtube70 facilitates the advancement of prosthetic valve 80 in a compressedstate, toward valve support 40.

FIG. 2H shows partial deployment of valve 80 within ventricle 6 of heart2. Valve 80 is shown comprising an expandable frame 79 comprising aplurality of stent struts by way of illustration and not limitation. Thewireframe of valve 80 comprises a flexible metal, e.g., nitinol orstainless steel. It is to be noted that the wireframe of valve 80 iscovered by a covering (not shown for clarity of illustration) comprisinga braided mesh or in a fabric such as a woven fabric, e.g., Dacron. Thecovering is typically configured to cover at least a portion of theframe. The covering may comprise a single piece, or a plurality ofpieces sewn together. Expandable frame 79 is typically self-expandable,although the scope of the present invention includes using a prostheticvalve that includes a balloon expandable frame, mutatis mutandis.

Following the partial deployment of valve 80 in ventricle 6, overtube 70is pulled proximally to pull valve 80 proximally such that cylindricalelement 42 and/or annular element 44 of valve support 40 surrounds aproximal portion of prosthetic valve 80. Valve 80 has a tendency toexpand such that valve 80 is held in place with respect to valve support40 responsively to radial forces acted upon valve support 40 byprosthetic valve 80.

Valve 80 comprises a plurality of distal protrusions 84 (e.g., snares).When valve 80 is pulled proximally, as described hereinabove,protrusions 84 ensnare and engage the native leaflets of theatrioventricular valve. By the ensnaring of the native leaflets,protrusions 84 sandwich the native valve between protrusions 84 andprosthetic valve support 40. Such ensnaring helps further anchorprosthetic valve 80 to the native atrioventricular valve. The scope ofthe present invention includes using any sort of protrusions (e.g.,hooks) that protrude from the distal end of expandable frame 79 ofprosthetic valve 80 and that are configured such that the native valveis sandwiched between the protrusions and valve support 40. Typically,the protrusions cause sandwiching of the native valve leaflets, suchthat the leaflets do not interfere with the left ventricular outflowtract (LVOT).

For some applications, protrusions 84 are such as to (a) preventproximal migration of the valve into the patient's atrium, while (b)allowing movement of the native leaflets with respect to the frame ofthe prosthetic valve. For example, the protrusions may have theaforementioned functionalities by having lengths of less than 5 mm,and/or by a total width of each set of protrusions corresponding torespective leaflets of the native valve being less than 5 mm. Forexample, the valve may include a single protrusion corresponding to eachleaflet of the native valve, the width of each of the single protrusionsbeing less than 1 mm. Thus, the valve may be stopped from proximallymigrating into the atrium, by the protrusions preventing the distal endof the valve from migrating further proximally than edges of nativeleaflets of the valve. Furthermore, the protrusions may allow movementof the native leaflets with respect to the frame of the prosthetic valveby not generally squeezing the native leaflets between the protrusionsand the frame of the valve. For some applications, by allowing movementof the native leaflets with respect to the frame of the prostheticvalve, sealing of the native leaflets against the outer surface of theframe of the prosthetic valve is facilitated, in accordance with thetechniques described hereinbelow with reference to FIG. 10 . Typically,valve support 40 prevents the valve from migrating distally into thepatient's ventricle.

For some applications, during the procedure, the prosthetic valve ispulled back proximally with respect to valve support, as describedhereinabove. The prosthetic valve is pulled back to a position withrespect to valve support that is such that protrusions 84 prevent thenative leaflets from interfering with the LVOT, by sandwiching thenative leaflets between the protrusions and the valve support, and/or byanchoring ends of the native leaflets as described hereinabove. Theprosthetic valve is then deployed at this position.

For some applications, protrusions are disposed on the valve on thesides of the valve that are adjacent to the anterior and posteriorleaflets of the native valve, and the valve does not includesprotrusions on the portions of the valve that are adjacent to thecommissures of the native valve, as described with reference to FIGS.11A-D. For some applications, the protrusions are disposed in asinusoidal configuration in order to conform with the saddle shape ofthe native valve, as described hereinbelow with reference to FIGS.12A-C.

Additionally, as shown in FIG. 2J, valve 80 comprises one or more (e.g.,a plurality, as shown) coupling elements 81 at the proximal end of valve80. Overtube 70, which facilitates the advancement of prosthetic valve80, is reversibly coupled to valve 80, via coupling elements 81.

Prosthetic valve 80 is configured for implantation in and/or at leastpartial replacement of a native atrioventricular valve 5 of the patient,such as a native mitral valve or a native tricuspid valve. Prostheticvalve 80 is configured to assume a collapsed state forminimally-invasive delivery to the diseased native valve, such as bypercutaneous or transluminal delivery using one or more catheters. FIG.2J shows prosthetic valve 80 in an expanded state after delivery to thenative valve.

Reference is now made to FIG. 2K which shows a bird's-eye view of valve80. Prosthetic valve 80 further comprises a plurality of valve leaflets82, which may be artificial or tissue-based. The leaflets are typicallycoupled to an inner surface of the valve prosthesis. Leaflets 82 arecoupled, e.g., sewn, to expandable frame 79 and/or to the covering. Forapplications in which the prosthetic valve is configured to be implantedat the native mitral valve, the prosthetic valve typically comprisesthree leaflets 82 a, 82 b, and 82 c, as shown in FIG. 2K.

Reference is now made to FIGS. 3A-D, which are schematic illustrationsof the advancement of prosthetic valve support 40 toward nativeatrioventricular valve 5 of a patient, the valve support including asealing balloon 90, in accordance with some applications of the presentinvention. The steps shown in FIGS. 3A-C are generally similar to thoseshown in FIGS. 2C-F. For some applications, sealing balloon 40 isdisposed on the valve-facing, lower side of annular element 44 of theprosthetic valve support. FIG. 3D shows valve support 40, the valvesupport having been implanted at annulus 11. Typically, at this stage,balloon 40 is inflated, as shown in the transition from FIG. 3C to FIG.3D. The balloon is inflated via an inflation lumen 92, shown in FIG. 3C,for example. For some applications, the balloon seals the interfacebetween the prosthetic valve support and native annulus 11, therebyreducing retrograde blood flow from ventricle 6 into atrium 4, relativeto retrograde blood flow in the absence of a sealing balloon. For someapplications, the balloon is inflated prior to the placement of theprosthetic support at annulus 11.

Reference is now made to FIGS. 4A-C, which are schematic illustrationsof prosthetic valve support 40 being used with commissural helices 100 aand 100 b that facilitate anchoring and/or sealing of the valve support,in accordance with some applications of the present invention. For someapplications, commissural helices are used as an alternative or inaddition to anchors 30 a and 30 b and/or other anchoring elementsdescribed herein, in order to facilitate the anchoring of valve support40.

Commissural helices 100 a and 100 b are typically placed at commissures8 and 10 in a generally similar technique to that described withreference to anchors 30 a and 30 b. Typically, each helix 30 a and 30 bis reversibly coupled to a respective delivery lumen 27 a and 27 b. Asdescribed above, each delivery lumen 27 slides around a respective guidemember 21, and a respective surrounding sheath 26 a and 26 b surroundseach delivery lumen 27 a and 27 b.

Commissural helices 100 a and 100 b (optionally, ribbed crimpingstructures 34), and the distal ends of surrounding sheaths 26 a and 26 bare advanced into ventricle 6. The helices are pushed out of the distalends of surrounding sheaths 26 a and 26 b. Subsequently, the helices arerotated proximally such that the helices wrap around at least somechordae tendineae 102 of the patient. Following the advancement of thehelices out of sheaths 26 a and 26 b, the sheaths are extracted. Forsome applications the helices are conical helices (as shown), and thewider end of the conical helix is disposed at the proximal end of thehelix.

Subsequent to the placement of commissural helices 100 a and 100 baround the chordae tendineae, prosthetic valve support 40 is placed atannulus 11, in accordance with the techniques described hereinabove, andas shown in FIG. 4B. Subsequently, prosthetic valve 80 is coupled to theprosthetic valve support, in accordance with the techniques describedhereinabove, and as shown in FIG. 4C.

Typically, commissural helices 100 a and 100 b facilitate sealing ofnative commissures 8 and 10, thereby reducing retrograde blood flow viathe commissures, relative to retrograde blood flow in the absence of thehelices. Further typically, the sealing of the native commissuresfacilitates anchoring of the prosthetic valve support to native valve 5.

Reference is now made to FIGS. 5A-D, which are schematic illustrationsof grasping elements 106 a and 106 b being used to anchor prostheticvalve 80, in accordance with some applications of the present invention.For some applications, guide members 21 a and 21 b are advanced towardfirst and second commissures 8 and 10 of valve 5 of the patient, asdescribed hereinabove. Grasping elements 106 a and 106 b are reversiblycoupled to distal ends of delivery lumen 27 a and 27 b, the deliverylumens being advanced over respective guide members, as describedhereinabove. For some applications, the guiding members and the graspingelements are advanced toward the patient's commissures via surroundingsheaths 26 a and 26 b, the surrounding sheaths being generally asdescribed hereinabove. The grasping elements are typically placeddistally to the commissures in a proximally-facing configuration, asshown in FIG. 5A. For example, as shown, the grasping elements may beconfigured to be proximally facing due to the coupling of the graspingelements to the guide members.

Subsequent to the placement of grasping elements 106 a and 106 bdistally to native commissures 8 and 10, prosthetic valve 80 is advancedtoward native valve 5, as shown in FIG. 5B. For example, the prostheticvalve may be advanced over delivery lumens 27 a and 27 b, as shown. Theprosthetic valve is placed at the native valve and, subsequently, thegrasping elements are retracted proximally toward commissures 8 and 10,as shown in the transition from FIG. 5B to FIG. 5C. For someapplications, the grasping elements are coupled to valve 80 via couplingtubes 107 a and 107 b, the coupling tubes being coupled to the sides ofthe valve, as shown. The grasping elements are closed such that thenative commissures are grasped and sealed by the grasping elements, asshown in FIG. 5D. Typically, the grasping elements define two surfacesthat are hingedly coupled to each other. For example, the graspingelements may include forceps, as shown. The grasping elements are closedby closing the surfaces about the hinge, with respect to one another.

Typically, grasping elements 106 a and 106 b facilitate sealing ofnative commissures 8 and 10, thereby reducing retrograde blood flow viathe commissures, relative to retrograde blood flow in the absence of thegrasping elements. Further typically, the sealing of the nativecommissures facilitates anchoring of the prosthetic valve to nativevalve 5.

Although not shown, for some applications, prosthetic valve support 40is used in addition to grasping elements 106 a and 106 b, in order toanchor prosthetic valve 80 to native valve 5. For some applications, thegrasping elements are used to anchor and/or provide sealing forprosthetic valve support 40 (instead of, or in addition to, being usedto anchor prosthetic valve 80, as shown). For such applications,generally similar techniques are used to those described with respect tothe use of the grasping elements for anchoring the prosthetic valve,mulatis mutandis.

Reference is now made to FIGS. 6A-B, which are schematic illustrationsof prosthetic valve 80, the prosthetic valve comprising a sealingmaterial 110 on an outer surface of the valve, in accordance with someapplications of the present invention. For some applications, prostheticvalve 80 is used in conjunction with prosthetic valve support 40, asdescribed hereinabove. The techniques for implanting prosthetic valve 80as shown in FIGS. 6A-B are generally similar to those describedhereinabove. Typically, sealing material 110 seals the interface betweenthe prosthetic valve and native valve 5. The sealing material reducesretrograde blood flow from ventricle 6 into atrium 4, relative toretrograde blood flow in the absence of the sealing material. Typically,the sealing material is composed of latex, dacron, and/or any othersuitable biocompatible material. The sealing material is typicallyplaced around at least a portion of expandable frame 79 of theprosthetic valve so as to form a webbing between struts of theexpandable frame.

Reference is now made to FIGS. 7A-F, which are schematic illustrationsof a guide wire delivery system, in accordance with some applications ofthe present invention. As described hereinabove (e.g., with reference toFIGS. 2C-F), for some applications, guide members 21 a and 21 b,function as valve support guide members, by support 40 being slid alongguide members 21 a and 21 b. For some applications, only one guidemember 21 is looped through commissures 8 and 10 in a manner in whichthe guide member defines a looped portion between commissures 8 and 10(i.e., a portion of the guide member that is disposed in a ventricle 6of heart 2), and first and second free ends, which are disposed andaccessible at a site outside the body of the patient. For suchapplications, the guide member defines portions 21 a and 21 b.

For some applications, an anchor 302 is advanced toward the vicinity ofapex 304 of heart 2, via sheath 25, and is anchored to the vicinity ofthe apex, as shown in FIG. 7A. A guidewire 306 extends proximally fromanchor. Guide member 21 passes through a guide member tube 320, theguide member tube being coupled to guidewire 306. Guide member 21 ispushed distally. Guide member tube 320 is unable to advance distallyover guidewire 306, due to the coupling of the guide member tube to theguidewire. Therefore, the pushing of guide member 21 distally, causesportions 21 a and 21 b to spread apart from one another and to be pushedagainst commissures 8 and 10 of native valve 5. Portions 21 a and 21 bare then used to guide valve support 40 to the commissures, as shown inFIGS. 7B-C, using generally similar techniques to those describedhereinabove, except for the differences described hereinbelow.

As shown in FIG. 7B, valve support 40 is slid over guide member portions21 a and 21 b, by pushing elements 52 a and 52 b. Since the guide memberportions are positioned at commissures 8 and 10, the guide memberportions guide the distal ends of pushing elements 52 a and 52 b, suchthat the pushing elements push the valve support against thecommissures, as shown in FIG. 7C.

Subsequent to the placement of valve support 40 at the native valve,prosthetic atrioventricular valve 80 is coupled to valve support 40. Forsome applications, pushing elements 52 a and 52 b continue to push thevalve support against the native valve, during the coupling of theprosthetic valve to the valve support. As described hereinabove,overtube 70 is advanced into ventricle 6, as shown in FIG. 7D. FIG. 7Eshows prosthetic valve having been partially deployed in the ventricle.Following the partial deployment of valve 80 in ventricle 6, overtube 70is pulled proximally to pull valve 80 proximally such that cylindricalelement 42 and/or annular element 44 of valve support 40 surrounds aproximal portion of prosthetic valve 80. Valve 80 has a tendency toexpand such that valve 80 is held in place with respect to valve support40 responsively to radial forces acted upon valve support 40 byprosthetic valve 80. During the pulling back of overtube 70, pushingelements 52 a and 52 b push valve support 40 against the valve, therebyproviding a counter force against which overtube 70 is pulled back. Forsome applications, the pushing of the valve support against thecommissures is such that it is not necessary to use anchors foranchoring the valve support to the native valve during the coupling ofthe prosthetic valve to the valve support. Alternatively, in addition tothe pushing elements providing a counter force against which theprosthetic valve is pulled, anchors are used to anchor the valve supportto the native valve during the coupling of the prosthetic valve to thevalve support.

As described hereinabove, valve 80 comprises a plurality of distalprotrusions 84. When valve 80 is pulled proximally, as describedhereinabove, protrusions 84 ensnare and engage the native leaflets ofthe atrioventricular valve. By the ensnaring of the native leaflets,protrusions 84 sandwich the native valve between protrusions 84 andprosthetic valve support 40. Such ensnaring helps further anchorprosthetic valve 80 to the native atrioventricular valve.

For some applications, as described hereinabove, protrusions 84 are suchas to (a) prevent proximal migration of the valve into the patient'satrium, while (b) allowing movement of the native leaflets with respectto the frame of the prosthetic valve. For example, the protrusions mayhave the aforementioned functionalities by having lengths of less than 5mm and/or by a total width of each set of protrusions corresponding torespective leaflets of the native valve being less than 5 mm. Forexample, the valve may include a single protrusion corresponding to eachleaflet of the native valve, the width of each of the single protrusionsbeing less than 1 mm. Thus, the valve may be stopped from proximallymigrating into the atrium, by the protrusions preventing the distal endof the valve from migrating further proximally than edges of nativeleaflets of the valve. Furthermore, the protrusions may allow movementof the native leaflets with respect to the frame of the prosthetic valveby not generally squeezing the native leaflets between the protrusionsand the frame of the valve. For some applications, by allowing movementof the native leaflets with respect to the frame of the prostheticvalve, sealing of the native leaflets against the outer surface of theframe of the prosthetic valve is facilitated, in accordance with thetechniques described hereinbelow with reference to FIG. 10 .

Subsequent to the placement of the prosthetic valve at the native valve,sheath 25, overtube 70, pushing elements 52 a and 52 b, guide member 21,anchor 302, and guidewire 306 are removed from the patient's body, asshown in FIG. 7F, which shows the prosthetic valve in its deployedstate. For some applications, in order to remove guide member 21 fromthe patient's body, guide member portions 21 a and 21 b are decoupledfrom guide member tube 320. For example, the guide member portions maybe coupled to the guide member tube via threading, the guide memberportions being decoupled from the guide member tube by unscrewing theguide member portions from the guide member tube.

Reference is now made to FIGS. 8A-C which are schematic illustrations ofa system 120 comprising an invertible valve support 140, in accordancewith some applications of the present invention. Invertible valvesupport 140 is identical to valve support 40 described herein, with theexception that the cylindrical element of valve support 140 isinvertible, as is described hereinbelow. Additionally, the method ofadvancing toward and implanting valve support 140 at annulus 11 isidentical to the methods of advancing toward and implanting valvesupport 40 at annulus 11, as described hereinabove.

Valve support 140 comprises an annular element 144 (that is identical toannular element 44 described hereinabove) and a cylindrical element 142.Cylindrical element 142 has a first end 150, a second end 152, and acylindrical body 153 disposed between first and second ends 150 and 152.Cylindrical element 142 is attached to annular element 144 at first end150 of cylindrical element 142.

During and following implantation of support 140 at annulus 11, as shownin FIG. 8A, cylindrical element 142 is disposed above annular element144 in a manner in which second end 152 and cylindrical body 153 aredisposed above annular element 144 and within atrium 4. One or moreelongate guide members 146 a and 146 b are reversibly coupled tocylindrical element 142 in a vicinity of second end 152. Elongate guidemembers 146 a and 146 b facilitate (a) advancement of prosthetic valve80 therealong and toward valve support 140, and (b) inversion ofcylindrical element 142 toward ventricle 6 when at least a portion ofvalve 80 is deployed within ventricle 6 (as shown in FIG. 8B).

The configuration of valve support 140 as shown in FIG. 8A (i.e., theconfiguration in which cylindrical element 142 is disposed within atrium4) eliminates the obstruction of native valve 5 and of leaflets 12 and14 by any portion of valve support 140. In this manner, valve support140 may be implanted at valve 5 while valve 5 resumes its nativefunction and leaflets 12 and 14 resume their natural function (as shownby the phantom drawing of leaflets 12 and 14 in FIG. 8A which indicatestheir movement). This atrially-inverted configuration of valve support140 reduces and even eliminates the amount of time the patient is undercardiopulmonary bypass. Only once prosthetic valve 80 is delivered andcoupled to valve support 140 and cylindrical element 142 is therebyventricularly-inverted, native leaflets 12 and 14 are pushed aside (FIG.8B).

FIG. 8B shows the inversion of cylindrical element 142 by the partialpositioning and deployment of prosthetic valve 80 within ventricle 6.Elongate guide members 146 a and 146 b are reversibly coupled toprosthetic valve 80 and extend within overtube 70. Following the fulldeployment of valve 80 and the coupling of valve 80 to valve support140, elongate guide members 146 a and 146 b are decoupled fromprosthetic valve 80 and from cylindrical element 142. For example, acutting tool may be used to decouple elongate members 146 a and 146 bfrom the valve support 140. Alternatively, elongate members 146 a and146 b may be looped through the cylindrical element 142, such that bothends of each elongate member 146 a and 146 b remain outside of thepatient's body. The operating physician decouples elongate members 146 aand 146 b from valve support 140 by releasing one end of each ofelongate members 146 a and 146 b and pulling on the other end, untilelongate members 146 a and 146 b are drawn from valve support 140 andremoved from within the body of the patient.

FIG. 8C shows prosthetic valve 80 coupled to valve support 140. Valve 80is identical to the valve described hereinabove.

Reference is now made to FIGS. 9A-E, which are schematic illustrationsof the advancement of an invertible prosthetic valve support 300 towarda native atrioventricular valve of a patient, and inversion of the valvesupport, in accordance with some applications of the present invention.Prosthetic valve support 300 is used to anchor prosthetic valve 80 tonative valve 5 in a generally similar manner to that described withreference to prosthetic valve support 40.

During a typical procedure, anchor 302 is advanced toward the vicinityof apex 304 of heart 2, via sheath 25, and is anchored to the vicinityof the apex, as shown in FIG. 8A. A guidewire 306 extends proximallyfrom anchor. A distal tensioning element 308 (e.g., a plunger) isadvanced over guidewire 306 into ventricle 6, and prosthetic valvesupport 300 is advanced out of the distal end of sheath 25, as shown inFIG. 9B. A first end 310 of prosthetic valve support 300 (which at thisstage is the distal end of the prosthetic valve support), comprisesbarbs 314 (shown in FIG. 9B), or other anchoring elements for anchoringthe first end of the prosthetic valve support to tissue of native valve5. Prosthetic valve support 300 is pushed distally such that the barbsare pushed into the native valve tissue, thereby anchoring the first endof the prosthetic valve support to the native valve, as shown in FIG.9C. A plurality of wires 309 pass from distal tensioning element 308 toa proximal tensioning element 311 (shown in FIG. 9D), via a second end312 of valve support 300 (which at this stage is the proximal end of theprosthetic valve support). For some applications, a sealing element 316is disposed circumferentially around a surface of the invertibleprosthetic valve support that is initially an inner surface of theinvertible prosthetic valve support (a shown in FIGS. 8A-D). Forexample, the sealing material may be latex, dacron, or another suitablebiocompatible sealing material.

Subsequent to the anchoring of first end 310 of prosthetic valve support300 to native valve tissue (as shown in FIG. 9C), distal tensioningelement 308 is further advanced distally into ventricle 6, and proximaltensioning element 311 is advanced toward the ventricle. As shown in thetransition from FIG. 9D-F, as the proximal tensioning element passesthrough the valve support, wires 309 cause valve support 300 to invert,by pulling second end 312 of the valve support through first end 310 ofthe valve support. Subsequent to the inversion of the valve support,sealing material 316 is disposed circumferentially around the outside ofthe valve support, thereby providing a seal at the interface betweenvalve support 300 and native valve 5.

Reference is now made to FIGS. 9G-H, which are schematic illustrationsof the deployment of prosthetic valve 80 and the coupling of theprosthetic valve to invertible valve support 300, in accordance withsome applications of the present invention.

The deployment of prosthetic valve 80 is generally similar to thetechniques described hereinabove with reference to FIGS. 2H-J. The valveis partially deployed in ventricle 6, via overtube 70. Following thepartial deployment of valve 80 in ventricle 6, overtube 70 is pulledproximally (as shown in FIG. 8G) to pull valve 80 proximally such thatvalve support 300 surrounds a proximal portion of prosthetic valve 80,as shown in FIG. 8H. Valve 80 has a tendency to expand such that valve80 is held in place with respect to valve support 300 responsively toradial forces acted upon valve support 300 by prosthetic valve 80.

As described hereinabove, for some applications, valve 80 comprises aplurality of distal protrusions 84. When valve 80 is pulled proximally,protrusions 84 ensnare and engage the native leaflets of theatrioventricular valve. By the ensnaring of the native leaflets,protrusions 84 sandwich the native valve between protrusions 84 andprosthetic valve support 300. Such ensnaring helps further anchorprosthetic valve 80 to the native atrioventricular valve.

For some applications, as described hereinabove, protrusions 84 are suchas to (a) prevent proximal migration of the valve into the patient'satrium, while (b) allowing movement of the native leaflets with respectto the frame of the prosthetic valve. For example, the protrusions mayhave the aforementioned functionalities by having lengths of less than 5mm, and/or by a total width of each set of protrusions corresponding torespective leaflets of the native valve being less than 5 mm. Forexample, the valve may include a single protrusion corresponding to eachleaflet of the native valve, the width of each of the single protrusionsbeing less than 1 mm. Thus, the valve may be stopped from proximallymigrating into the atrium, by the protrusions preventing the distal endof the valve from migrating further proximally than edges of nativeleaflets of the valve. Furthermore, the protrusions may allow movementof the native leaflets with respect to the frame of the prosthetic valveby not generally squeezing the native leaflets between the protrusionsand the frame of the valve. For some applications, by allowing movementof the native leaflets with respect to the frame of the prostheticvalve, sealing of the native leaflets against the outer surface of theframe of the prosthetic valve is facilitated, in accordance with thetechniques described hereinbelow with reference to FIG. 10 .

Additionally, as shown in FIG. 9H, and as described hereinabove, valve80 comprises one or more coupling elements 81 (for example, a pluralityof coupling elements, as shown) at the proximal end of valve 80.Overtube 70, which facilitates the advancement of prosthetic valve 80,is reversibly coupled to valve 80, via coupling elements 81.

Subsequent to the coupling of valve 80 to valve support 300, overtube70, distal and proximal tensioning elements 308 and 311, and wires 309are removed from the patient's body, via sheath 25. Typically, wires 309are cut, in order to facilitate the removal of the wires from thepatient's body. Guidewire 306 and anchor 302 are removed from thepatient's body by detaching the anchor from apex 304, and withdrawingthe anchor and the guidewire, via sheath 25.

Reference is now made to FIG. 10 , which is a schematic illustration ofprosthetic valve 80, for placing inside atrioventricular valve 5 of thepatient, in accordance with some applications of the present invention.The expandable frame 79 of the prosthetic valve has a diameter d, and acorresponding cross-sectional area. Native annulus 11, which istypically saddle-shaped, defines an area A, as shown. For someapplications, area A, which is defined by the native annulus ismeasured, e.g., using a measuring ring. A prosthetic valve is chosen tobe placed in the annulus, the cross-sectional area of the prostheticvalve being less than 90% (e.g., less than 80%, or less than 60%) ofarea A. For some applications, diameter d of the prosthetic valve isless than 25 mm, e.g., less than 20 mm, and/or more than 15 mm, e.g.,15-25 mm. For some applications, placing a prosthetic valve inside thenative valve with the dimensions of the native valve annulus and theprosthetic valve as described, facilitates sealing of the prostheticvalve with respect to the native valve, by the native valve leafletsclosing around the outer surface of the prosthetic valve.

For some applications, a prosthetic valve support 40 that includesannular element 44 (e.g., as shown in FIGS. 14A-C) is chosen to beplaced at the annulus, the annular element defining an innercross-sectional area that is less than 90% (e.g., less than 80%, or lessthan 60%) of area A. Prosthetic valve 80 is deployed at the native valveby coupling the prosthetic valve to the prosthetic valve support at thelocation, responsively to radial forces acted upon the valve support bythe expandable frame, by facilitating expansion of the expandable frame,as described herein. The cross-sectional area defined by the expandableframe of the prosthetic valve, upon expansion of the expandable frame,is limited by the cross-sectional area defined by the annular element ofthe prosthetic valve support to less than 90% (e.g., less than 80%, orless than 60%) of area A. For some applications, placing a prostheticvalve support at the annulus with the dimensions of the native valveannulus and valve support 40, as described, facilitates sealing of theprosthetic valve with respect to the native valve, by the native valveleaflets closing around the outer surface of the prosthetic valve.

Typically, placing a prosthetic valve inside the native valve with thedimensions of the native valve annulus, the prosthetic valve 80, and/orvalve support 40 as described in the above paragraphs, facilitatessealing of the prosthetic valve with respect to the native valve. Forsome applications, the sealing is facilitated by the native leafletsbeing pushed against, and closing against, the outer surface of theframe of the valve during systole, in a similar manner to the manner inwhich native valve leaflets coapt during systole, in a healthy mitralvalve. Typically, as the diameter of the prosthetic valve is increased,the length of the native leaflets that is pushed against the outersurface of the valve during systole is increased, thereby enhancing thesealing of the native leaflets with respect to the frame of theprosthetic valve. However, beyond a given diameter, as the diameter ofthe prosthetic valve is increased, the native valve leaflets are pushedapart at the commissures, thereby causing retrograde leakage of bloodthrough the commissures. Therefore, in accordance with some applicationsof the present invention, prosthetic valve 80, and/or valve support 40are chosen such that the cross-sectional area of the prosthetic valvewhen expanded inside the valve support is less than 90% (e.g., less than80%, or less than 60%) of area A. Thus the valve support facilitatessealing of the prosthetic valve with respect to the native valve, by thenative valve leaflets closing around the outer surface of the prostheticvalve, while not causing retrograde leakage of blood through thecommissures.

For some applications, in order to facilitate the sealing of the nativevalve around the outer surface of the prosthetic valve, a material isplaced on the outer surface of the prosthetic valve in order to providea sealing interface between the prosthetic valve and the native valve.For example, a smooth material that prevents tissue growth (e.g.,polytetrafluoroethylene (PTFE), and/or pericardium) may be placed on theouter surface of the prosthetic valve. Alternatively or additionally, amaterial that facilitates tissue growth (such as dacron) may be placedon the outer surface of the prosthetic valve, in order to (a) act as asealing interface between the native valve and the prosthetic valve, and(b) facilitate tissue growth around the prosthetic valve to facilitateanchoring and/or sealing of the prosthetic valve.

Reference is now made to FIGS. 11A-D, which are schematic illustrationsof prosthetic valve 80, in accordance with some applications of thepresent invention. For some applications, protrusions 84 are disposed onthe valve on portions 400 of the valve that are placed adjacent to theanterior and posterior leaflets of the native valve, and the valve doesnot includes protrusions on portions 402 of the valve that are placedadjacent to the commissures of the native valve.

FIGS. 11B-D show bottom views (i.e., views of the distal ends) ofrespective configurations of prosthetic valve 80 and protrusions 84. Theprotrusions converge from the proximal ends 404 of the protrusion to thedistal ends 406 of the protrusions. The protrusions are configured suchas to ensnare chordae tendineae, and to pull the chordae tendineaetoward each other when the prosthetic valve is pulled proximally, due tothe convergence of the snares with respect to each other. FIG. 11D showsthe prosthetic valve deployed at native valve 5. As shown, theprotrusions ensnare chordae tendineae 102 of the patient. Theprotrusions facilitate sealing and anchoring of the prosthetic valvewith respect to the native valve by pulling the chordae tendinae towardeach other, as described. As described hereinabove, for someapplications the prosthetic valve does not define protrusions 84 onportions 402 that are placed next to the native commissures, e.g.,commissure 8, shown in FIG. 11D.

For some applications, as described hereinabove, protrusions 84 are suchas to (a) prevent proximal migration of the valve into the patient'satrium, while (b) allowing movement of the native leaflets with respectto the frame of the prosthetic valve. For example, the protrusions mayhave the aforementioned functionalities by having lengths of less than 5mm, and/or by a total width of each set of protrusions corresponding torespective leaflets of the native valve being less than 5 mm. Forexample, the valve may include a single protrusion corresponding to eachleaflet of the native valve, the width of each of the single protrusionsbeing less than 1 mm. Thus, the valve may be stopped from proximallymigrating into the atrium, by the protrusions preventing the distal endof the valve from migrating further proximally than edges of nativeleaflets of the valve. Furthermore, the protrusions may allow movementof the native leaflets with respect to the frame of the prosthetic valveby not generally squeezing the native leaflets between the protrusionsand the frame of the valve. For some applications, by allowing movementof the native leaflets with respect to the frame of the prostheticvalve, sealing of the native leaflets against the outer surface of theframe of the prosthetic valve is facilitated, in accordance with thetechniques described hereinabove with reference to FIG. 10 .

For some applications, a first set of protrusions 84 from the distal endof prosthetic valve 80 are disposed within a first circumferential arcwith respect to a longitudinal axis of the prosthetic valve, on a firstside of the distal end of the prosthetic valve, the first side of thedistal end being configured to be placed adjacent to the anteriorleaflet of the native valve. A second set of protrusions are disposedwithin a second circumferential arc with respect to a longitudinal axisof the prosthetic valve, on a second side of the distal end of theprosthetic valve, the second side of the distal end being configured tobe placed adjacent to the posterior leaflet of the native valve.

The first and second sets of protrusions are disposed so as to providefirst and second gaps therebetween at the distal end of the prostheticvalve. Typically, at least one of the gaps between the two sets ofprotrusions has a circumferential arc of at least 20 degrees (e.g., atleast 60 degrees, or at least 100 degrees), and/or less than 180 degrees(e.g., less than 140 degrees), e.g., 60-180 degrees, or 100-140 degrees.Further typically, one or both of the first and second circumferentialarcs defines an angle of at least 25 degrees (e.g., at least 45degrees), and/or less than 90 degrees (e.g., less than 75 degrees),e.g., 25-90 degrees, or 45-75 degrees.

Valve guide members (e.g., guide members 21 a and 21 b, and/or deliverylumen 27 a and 27 b, as described hereinabove) are delivered tocommissures of the native valve, and guide the valve such that the firstand second circumferential arc are aligned with respective leaflets ofthe native valve and such that the first and second gaps are alignedwith respective commissures of the native valve.

Reference is now made to FIGS. 12A-C, which are schematic illustrationsof prosthetic valve 80, the valve defining distal protrusions 84 thatare disposed sinusoidally around the circumference of the valve, inaccordance with some applications of the present invention. For someapplications the protrusions are shaped sinusoidally, in order toconform with the saddle-shape of native valve annulus 11, therebyfacilitating the sandwiching of the native valve leaflets between theprotrusions and valve support 40. As shown, the peaks of the sinusoidthat is defined by the protrusions is disposed on portions 402 that areplaced next to the native commissures and the troughs of the sinusoid isplaced on portions of the valve that are placed in the vicinity of thecenters of the anterior and posterior leaflets of the native valve. Asshown in FIG. 12C, for some applications the distal end of theprosthetic valve defines a sinusoidal shape.

Reference is now made to FIGS. 13A-E, which are schematic illustrationsof respective configurations of expandable frame 79 of prosthetic valve80, in accordance with some applications of the present invention. Asdescribed hereinabove, for some applications, valve 80 defines distalprotrusions 84 that are configured to facilitate sandwiching of thenative valve leaflets between the protrusions and valve support 40. Forsome applications, tips of the distal protrusions are shaped so as toprevent the tips from piercing, and/or otherwise damaging, tissue of thenative leaflets. For example, the tips of the protrusions may be curved,as shown in FIG. 13A. Or, the distal tips of the protrusions may beshaped as balls, as shown in FIG. 13 , and/or a different rounded shape.For some applications, the distal tip of each of the protrusions isjoined to the distal tip of an adjacent protrusion by an arch 410, asshown in FIGS. 13C and 13D.

For some applications, the protrusions are configured to bedistally-facing during the insertion of prosthetic valve 80 into thesubject's left ventricle. For example, the valve may be inserted throughovertube 70 (shown in FIG. 7E, for example). The valve is crimped duringthe insertion of the valve through the overtube, and the protrusions areconstrained in their distally-facing configurations by the overtube. Theprotrusions are pre-shaped such that in the resting state of theprotrusions, the protrusions assume proximally-facing configurations, asshown in FIG. 13D, for example. Thus, upon emerging from overtube 70,the protrusions assume proximally-facing configurations. For someapplications, when the protrusions assume the proximally-facingconfigurations, the protrusions are disposed at an angle theta (FIG.13D) from expandable frame 79 of more than 40 degrees (e.g., more than50 degrees), and/or less than 80 degrees (e.g., less than 70 degrees).

Typically, protrusions 84 are coupled to frame 79 of valve 80 at joints412. For some applications, joints 412 are thinner than portions of theprotrusions and of the frame surrounding the joints, as shown in FIG.13D. For some applications, the thinness of the joints with respect tothe surrounding portions facilitates the crimping of the protrusionsinto distally-facing configuration during the insertion of the valveinto the heart.

For some applications, barbs 416 extend from a proximal portion ofexpandable frame 79 of valve 80, as shown in FIG. 13E. For example, thebarbs may be configured to anchor the prosthetic valve to the nativevalve by piercing tissue of the native valve. Alternatively oradditionally, the barbs may be configured to anchor the prosthetic valveto the valve support 40, by becoming coupled to portions of the valvesupport. For some applications the barbs protrude from the top-centralcorner of respective cells of expandable frame 79. Typically, when theprosthetic valve is crimped, the barbs fit within gaps of respectivecells of the expandable frame, and do not substantially increase thecrimping profile of the prosthetic valve, relative to a generallysimilar prosthetic valve that does not include barbs.

For some applications, the barbs are not generally used for couplingprosthetic valve support 80 to valve support 40. Rather, the prostheticvalve is coupled to the valve support by virtue of radial expansion ofthe prosthetic valve against annular element 44 of the valve support.Barbs 416 are used to prevent prosthetic valve from migrating distallyinto the patient's left ventricle, and/or to prevent valve support 40from migrating proximally into the subject's left atrium.

For some applications (not shown), barbs protrude from coupling elements81 of prosthetic valve 80, the barbs being generally similar in shapeand function to that described with reference to barbs 416. For someapplications (not shown), radially-inwardly facing barbs 45 protrudefrom annular element 44 of valve support 40, as shown in FIG. 14D. Asdescribed with reference to barbs 416, the barbs that protrude fromannular element 44 may facilitate coupling of the prosthetic valve tothe valve support. Alternatively or additionally, the barbs thatprotrude from annular element 44 are used to prevent prosthetic valvefrom migrating distally into the patient's left ventricle, and/or toprevent valve support 40 from migrating proximally into the subject'sleft atrium.

For some applications, a proximal end of expandable frame 79 ofprosthetic valve 80 defines a larger cross-section area than more distalportions of the expandable frame. For example, the expandable frame mayhave a frustoconical shape, the walls of the expandable frame divergingfrom a distal end of the frame to a proximal end of the frame.Alternatively, the expandable frame may have a trumpet shape (i.e., theframe may be generally tubular, with a dilated proximal end). For someapplications, the larger cross-sectional area of the proximal end of theframe prevents the prosthetic valve from migrating distally into thepatient's left ventricle, and/or prevents valve support 40 frommigrating proximally into the subject's left atrium.

Reference is now made to FIGS. 14A-D, which are schematic illustrationsof respective configurations of prosthetic valve support 40, inaccordance with some applications of the present invention. As describedhereinabove, for some applications, the valve support comprises acollapsible skirt having a proximal annular element 44 and a distalcylindrical element 42 (e.g., as shown in FIG. 2D). Alternatively, thevalve support does not include a distal cylindrical element. Forexample, the valve support may only include annular element 44. Asdescribed hereinabove, annular element 44 is configured to be placedaround native annulus 11 of the native valve, and to extend at leastpartially into atrium 4 such that annular element 44 rests against thenative annulus. Annular element 44 is typically too large to passthrough the annulus, and may, for example, have an outer diameter ofbetween 30 and 60 mm.

FIGS. 14A-D show annular element 44 of valve support 40 in respectiveconfigurations, in accordance with some applications of the presentinvention. For some applications, the annular element is D-shaped, asshown in FIG. 14A. Alternatively or additionally, the annular elementhas a generally round shape, as shown in FIGS. 14B-C. For someapplications the annular element is asymmetrical. For example, FIG. 14Bshows a generally rounded annular element that is wider on a first side420 of the element than on a second side 422 of the element. Typically,the wider side of the annular element is placed on the anterior side ofthe native annulus. In accordance with some applications, the annularelement is symmetrical, asymmetrical, oval, round, defines a hole thatis centered with respect to the annular element, and/or defines a holethat is off-center with respect to the annular element. For someapplications, the stiffness of the annular element varies around thecircumference of the annular element.

For some applications, annular element 44 is asymmetrical, as shown inFIG. 14B. Typically, the asymmetry of the annular element is such thatthe center of the hole defined by the annular element is disposedasymmetrically (i.e., off-center) with respect to the center of theannular element, as defined by the outer perimeter of the annularelement. For some applications, the asymmetric disposition of the centerof the hole defined by the annular element is such that when theprosthetic valve is placed inside the annular element, the longitudinalaxis of the prosthetic valve is disposed asymmetrically (i.e.,off-center) with respect to the center of the annular element, asdefined by the outer perimeter of the annular element. Typically, theannular element is shaped such that, when the annular element is placedon the patient's mitral annulus, and the prosthetic valve is expandedinside the annular element, the longitudinal axis of the prostheticvalve is disposed in the vicinity of the location at which the patient'snative leaflets coapt (this location being off-center with respect tothe patient's native mitral annulus).

For some applications (not shown), radially-inwardly facing barbs 45protrude from annular element 44 of valve support 40, as shown in FIG.14D. As described with reference to barbs 416 shown protruding fromprosthetic valve 80 in FIG. 13E, the barbs that protrude from annularelement 44 may facilitate coupling of the prosthetic valve to the valvesupport. Alternatively or additionally, the barbs that protrude fromannular element 44 are used to prevent prosthetic valve from migratingdistally into the patient's left ventricle, and/or to prevent valvesupport 40 from migrating proximally into the subject's left atrium. Forsome applications, some or all of barbs 102 are curved. Typically, thecurved barbs curve away from the plane of annular element 40, such that,when implanted, barbs 102 point into the patient's atrium.

Typically, the annular element includes frame 48, the frame beingcovered at least in part with covering 49, e.g., fabric. Typically, theupper surface of annular element 44 is covered with fabric, for example,in order to provide a generally smooth surface for coming into contactwith the patient's blood flow. Further typically, the lower surface ofthe annular element (i.e., the side of the annular element that isplaced in contact with the native annulus) is not covered with fabric,for example, in order to reduce a crimped volume (or cross-sectionalarea) of the annular element, relative to the volume of the annularelement if the lower surface of the annular element were covered infabric. Typically, a thickness of the fabric layer is less than 0.2 mm,e.g., less than 0.1 mm, or less than 0.05 mm.

For some applications, the side of the annular element that is placed incontact with the native annulus is covered with the fabric, the fabricbeing configured to facilitate coupling of the annular element to thenative annulus, by facilitating fibrosis at the interface between theannular element and the native annulus. For some applications, the uppersurface of the annular element is not covered with fabric. For example,the upper surface may not be covered in fabric in order to reduce acrimped volume (or cross-sectional area) of the annular element,relative to the volume of the annular element if the upper surface ofthe annular element were covered in fabric.

For some applications, annular element 44 is not covered with fabric,and/or is not configured to form a seal against frame 79 of prostheticvalve 80. For some applications, the annular element is configured toallow leakage of blood between the annular element and frame 79 ofprosthetic valve 80. For example, the annular element may be configuredto allow leakage of blood through the interface between the annularelement and the frame of the prosthetic valve, in order to accommodate aflow of blood between the patient's atrium and the patient's ventriclethat is greater than can be accommodated by blood flowing through theleaflets of the prosthetic valve.

Reference is now made to FIGS. 15A-E, which are schematic illustrationsof respective steps of a procedure for deploying a prosthetic valve, inaccordance with some applications of the present invention. As describedhereinabove and hereinbelow (for example, with reference to FIGS. 2A-K,7A-F, 8A-C, 9A-H, and 16A-G), for some procedures, valve support 40 isplaced on the valve annulus and, subsequently, prosthetic valve 80 isinserted into the subject's left ventricle through the valve support.Alternatively, any of the procedures described herein (for example,procedures described with reference to FIGS. 2A-K, 7A-F, 8A-C, 9A-H, and16A-G) may be performed by first placing the prosthetic valve inside thesubject's left ventricle, and, subsequently, deploying the valve supportat the annulus. For example, FIGS. 15A-E show a procedure in which theprosthetic valve is placed inside the subject's left ventricle, and,subsequently, the valve support is deployed at the annulus.

As shown in FIG. 15A, for some applications, prosthetic valve 80 isplaced in the subject's ventricle, before prosthetic valve support 40 isplaced at the native valve. The prosthetic valve is typically placed inthe left ventricle in an undeployed state, via overtube 70.Subsequently, the valve support is placed at the native valve usingpushing elements, as shown in FIG. 15B. For some applications, threepushing elements 52 a, 52 b, and 52 c are used to push the valve supportagainst the native valve, as shown in FIG. 15B.

Subsequent to the placement of valve support 40 at the native valve,prosthetic valve 80 is coupled to valve support 40. For someapplications, pushing elements 52 a, 52 b, and 52 c continue to push thevalve support against the native valve, during the coupling of theprosthetic valve to the valve support. FIG. 15C shows prosthetic valvehaving been partially deployed in the ventricle.

Following the partial deployment of valve 80 in ventricle 6, overtube 70is pulled proximally to pull valve 80 proximally such that annularelement 44 of valve support 40 surrounds a proximal portion ofprosthetic valve 80, as shown in FIG. 15D. Valve 80 has a tendency toexpand such that valve 80 is held in place with respect to valve support40 responsively to radial forces acted upon valve support 40 byprosthetic valve 80. During the pulling back of overtube 70, pushingelements 52 a, 52 b, and 52 c push valve support 40 against the valve,thereby providing a counter force against which overtube 70 is pulledback. For some applications, the pushing of the valve support againstthe commissures is such that it is not necessary to use anchors foranchoring the valve support to the native valve during the coupling ofthe prosthetic valve to the valve support. Alternatively, in addition tothe pushing elements providing a counter force against which theprosthetic valve is pulled, anchors are used to anchor the valve supportto the native valve during the coupling of the prosthetic valve to thevalve support.

As described hereinabove, valve 80 comprises a plurality of distalprotrusions 84. When valve 80 is pulled proximally, as describedhereinabove, protrusions 84 ensnare and engage the native leaflets ofthe atrioventricular valve. By the ensnaring of the native leaflets,protrusions 84 sandwich the native valve between protrusions 84 andprosthetic valve support 40. Such ensnaring helps further anchorprosthetic valve 80 to the native atrioventricular valve.

It is noted with reference to FIG. 15D that, typically, annular element44 of prosthetic valve support 40 defines an inner cross-sectional areathereof. As described hereinabove, prosthetic valve 80 includesexpandable frame 79, and prosthetic leaflets 82. The expandable frame ofthe prosthetic valve is configured such that when the frame is in anon-constrained state thereof, the cross-sectional area of the frame,along at least a given portion L (shown in FIG. 15D) of the length ofthe frame, is greater than the inner cross-sectional area defined by theannular element of the prosthetic valve support. Typically, during avalve-deployment procedure, a location anywhere along portion L at whichto couple the expandable valve to the prosthetic valve support isselected. In response thereto, the location along the portion of theexpandable frame is aligned with the annular element of the prostheticvalve support. The expandable valve is then coupled to the prostheticvalve support at the location, responsively to radial forces acted uponthe valve support by the expandable frame, by facilitating expansion ofthe expandable frame, when the location along the portion is alignedwith the annular element of the prosthetic valve support.

As described hereinabove, for some applications, expandable frame 79 ofprosthetic valve 80 has a frustoconical shape. For some applications,the prosthetic valve is coupled to valve support 40 responsively toradial forces acted upon the valve support by the expandable frame, whena given location along portion L is aligned with annular element 44 ofthe prosthetic valve support. For some applications, the portionimmediately proximal to the given location along portion L has a greatercross-sectional area than the frame at the given location, due to thefrustoconical shape of the expandable frame. Typically, the greatercross-sectional area of the portion immediately proximal to the givenlocation along portion L relative to the cross-sectional area of theframe at the given location, reduces distal migration of the prostheticvalve toward the subject's left ventricle.

For some applications, the location along portion L at which to coupleprosthetic valve 80 to valve support 40 is selected, based upon adistance D between protrusions 84 and annular element 44 that wouldresult from coupling the prosthetic valve to the annular element at thatlocation. For example, the location along portion L at which to coupleprosthetic valve 80 to valve support 40 may be selected, such thatdistance D is such as to anchor the prosthetic valve to the patient'snative valve by squeezing the patient's native valve leaflets betweenthe protrusions and the annular element, and/or by ensnaring thepatient's chordae tendinae between the protrusions and the annularelement. Alternatively or additionally, the location along portion L atwhich to couple prosthetic valve 80 to valve support 40 may be selected,such that distance D is such that protrusions 84 (a) prevent proximalmigration of the valve into the patient's atrium, while (b) allowingmovement of the native leaflets with respect to the frame of theprosthetic valve. Typically, the location along portion L is selectedsuch that distance D is such that the valve may be stopped fromproximally migrating into the atrium, by the protrusions preventing thedistal end of the valve from migrating further proximally than edges ofnative leaflets of the valve, while the protrusions allow movement ofthe native leaflets with respect to the frame of the prosthetic valve bynot generally squeezing the native leaflets between the protrusions andthe frame of the valve. For some applications, by allowing movement ofthe native leaflets with respect to the frame of the prosthetic valvesealing of the native leaflets against the outer surface of the frame ofthe prosthetic valve is facilitated, in accordance with the techniquesdescribed hereinabove with reference to FIG. 10 .

Subsequent to the placement of the prosthetic valve at the native valve,overtube 70, and pushing elements 52 a, 52 b, and 52 c are removed fromthe patient's body, as shown in FIG. 15E, which shows the prostheticvalve in its deployed state.

Reference is now made to FIGS. 16A-G, which are schematic illustrationsof respective steps of an alternative procedure for deploying prostheticvalve 80, in accordance with some applications of the present invention.As described hereinabove, with reference to FIGS. 7A-F, for someapplications, a looped guide member 21 is looped through commissures 8and 10 in a manner in which the guide member defines a looped portionbetween commissures 8 and 10. For some applications, the looped guidemember has steering functionality. The steering functionality of thelooped guide member is used to guide the guide member to thecommissures, and/or to guide other portions of the apparatus to thenative valve and/or to ventricle 6. The looped guide member is typicallyadvanced toward ventricle 6 over guidewire 306, e.g., as describedhereinabove with reference to FIG. 7A.

Typically, as shown in FIG. 16A, portions 21 a and 21 b of the loopedguide member are independently manipulable. The portions of the loopedguide member are manipulated (e.g., expanded and contracted) so as toguide the looped guide member to the subject's native valve, by pushingagainst inner surfaces of the subject's heart, as shown in FIG. 16A.

FIG. 16B shows the looped guide member looped through commissures 8 and10 of the subject's native valve. When the looped guide member isdisposed at the native valve, the guide member is used to guide and toanchor valve support 40, as described hereinbelow.

As shown in FIG. 16C, for some applications, looped guide member 21 iscoupled to valve support 40 via coupling wires 500 and couplingmechanisms 502. For example, as shown, the coupling mechanism mayinclude an anchor. A suture 504, or a different looped element,protrudes from the bottom surface of annular element 44 of valve support40 and is anchored by the anchor. Thus, when looped guide member 21 ispushed distally into ventricle 6, the valve support is pulled againstthe annulus of the native valve by coupling wires 500 pulling on thevalve support.

Typically, coupling mechanisms 502, which are used to couple loopedguide member 21 to valve support 40 are detachable coupling mechanisms.For example, as shown, the coupling mechanism may include an anchor thatdefines an opening 506 through which suture 504 is inserted. The openingis closed by a closing member 508, such as a rod, or a wire. In order todetach the guide member from valve support, closing member 508 is opened(e.g., by being pulled proximally) such that suture 504 is releasedthrough opening 506.

Subsequent to the placement of valve support 40 at the native valve,prosthetic atrioventricular valve 80 is placed in ventricle 6, byadvancing overtube 70 into the ventricle, as shown in FIG. 16D. FIG. 16Eshows prosthetic valve having been partially deployed in the ventricle.Following the partial deployment of valve 80 in ventricle 6, overtube 70is pulled proximally to pull valve 80 proximally such that annularelement 44 of valve support 40 surrounds a proximal portion ofprosthetic valve 80, as shown in FIGS. 16E-F. Valve 80 has a tendency toexpand such that valve 80 is held in place with respect to valve support40 responsively to radial forces acted upon valve support 40 byprosthetic valve 80.

During the pulling back of overtube 70, looped guide member 21 is pusheddistally, thereby pulling valve support 40 against the native annulusand providing a counter force against which overtube 70 is pulled back.For some applications, pulling of the valve support against the nativeannulus is such that it is not necessary to use anchors for anchoringthe valve support to the native valve during the coupling of theprosthetic valve to the valve support. Alternatively, in addition to thepulling of the valve support against the native annulus providing acounter force against which the prosthetic valve is pulled, anchors areused to anchor the valve support to the native valve during the couplingof the prosthetic valve to the valve.

FIG. 16G shows prosthetic valve 80 and valve support 40 coupled to thenative valve. At this stage, coupling mechanism 502 is typicallydetached from the valve support. For example, as shown, closing member508 is pulled, such that opening 506 is opened, and suture 504 isreleased through the opening. Subsequently, looped guide member 21, andovertube 70 are removed from the subject's body, as shown in FIG. 16H,which shows the prosthetic valve in its deployed state.

As described with reference to FIGS. 16A-H, for some applications,prosthetic valve 80 is coupled to a native valve, by (a) placing valvesupport 40 on an atrial side of the native annulus, (b) placing theprosthetic valve inside the ventricle, and then, simultaneously, (c)pulling the prosthetic valve toward the atrium, and pulling the valvesupport toward the ventricle.

Reference is now made to FIGS. 17A-C, which are schematic illustrationsof leaflets 82 of prosthetic valve 80, in accordance with someapplications of the present invention. FIG. 17A shows the leafletsbefore the leaflets are sutured to expandable frame 79 of the valve. Asshown, in this state, the leaflets have a diameter D1, and the leafletsare not fully closed. FIG. 17B shows the leaflets when the leaflets havebeen sutured to expandable frame 79 of the prosthetic valve. Theexpandable frame constrains the leaflets, such that the leaflets definea diameter D2, which is smaller than diameter D1, thereby closing theleaflets. FIG. 17C shows the leaflets subsequent to the deployment ofvalve 80 inside valve support 40, the valve support constraining theexpansion of the prosthetic valve. Due to the valve support constrainingthe prosthetic valve, the valve leaflets are constrained so as define adiameter D3, which is smaller than diameter D2.

Typically, valve leaflets 82 are selected to be used in prosthetic valve80, the leaflets being sized such that both at diameter D2 (when theleaflets are constrained by expandable frame 79 but are not constrainedby valve support 40) and at diameter D3 (when the leaflets areconstrained by both expandable frame 79 and valve support 40), the valveleaflets fully coapt.

Reference is now made to FIGS. 18A-B which are schematic illustrationsof a system 220 comprising a valve support 240 comprising an annularelement 244 and a cylindrical element 242 and one or more (e.g., aplurality, as shown, of) tissue anchors 230, in accordance with someapplications of the present invention. Annular element 244 has an uppersurface 241 and a lower surface 243. Tissue anchors 230 are coupled tolower surface 234 of annular element. Tissue anchors 230 are shaped soas to define a pointed distal tip 234 and one or more (e.g., three, asshown) radially-expandable prongs 232. Prongs 232 comprise a flexiblemetal, e.g., nitinol or stainless steel, and have a tendency to expandradially. Anchors 230 facilitate coupling of valve support 240 toannulus 11 of native valve 5, such as the mitral valve or the tricuspidvalve. Anchors 230 are typically distributed approximately evenly aroundlower surface 243 of annular element 244. For some applications, one ormore anchors 230 are disposed at a location of annular element that isconfigured to be positioned adjacently to commissures 8 and 10 of valve5.

Reference is now made to FIGS. 19A-D which are schematic illustrationsof valve support 240 being implanted at valve 5 and the subsequentcoupling of prosthetic valve 80 to valve support 240. Valve support 240is advanced toward native valve 5 by pushing elements 52 a and 52 b, asdescribed hereinabove with respect to valve support 40 with reference toFIGS. 2D-F. In response to the pushing force to valve support 240 bypushing elements 52 a and 52 b, anchors 230 are pushed into tissue ofannulus 11 of valve 5. The pushing force by elements 52 a and 52 b issufficient to implant each one of the plurality of anchors that aredistributed around lower surface 243 of annular element 244.

FIG. 19A shows initial penetration of tissue of annulus 11 by pointeddistal tip 234 of anchor 230. In FIG. 19B, the initial force of thetissue on prongs 232 pushes inwardly prongs 232. Finally, in FIG. 19C,prongs 232 expand within tissue of annulus 11 to assume a flower shapeand a larger surface area to restrict proximal motion of anchor 230 andthereby anchor valve support 240 in tissue of annulus 11. As shown inFIGS. 19A-C, the cylindrical element of valve support 240 pushes asidenative leaflets 12 and 14 of valve 5.

In FIG. 19D, prosthetic valve 80 is coupled to valve support 240, in amanner as described hereinabove.

It is noted that, in general, prosthetic valve 80 is self-expandable.When the prosthetic valve is deployed (i.e., when the valveself-expands) inside the subject's heart, the expansion of the valve istypically constrained by valve support 40. Further typically, theexpansion of the valve is not constrained by the native annulus.

For some application, by constraining the expansion of the prostheticvalve with the valve support, the deployed cross-sectional area of theprosthetic valve may be fixed at a given area, by using a valve supportthat defines a hole having the given cross-sectional area. As describedhereinabove with reference to FIG. 10 , for some applications, the areadefined by the native annulus is measured, and the cross-sectional areaof the prosthetic valve that is to be deployed in the valve is selectedbased upon the measured area of the native annulus. Alternatively oradditionally, valve support 40 is selected based upon the measured areaof the native annulus.

For example, a valve support may be selected such that the valve supportconstrains the expansion of the prosthetic valve, when thecross-sectional area of the prosthetic valve is less than 90% (e.g.,less than 80%, or less than 60%) of the area defined by the nativeannulus. As described hereinabove, for some applications, placing aprosthetic valve inside the native valve with the dimensions of thenative valve annulus and the prosthetic valve being as described,facilitates sealing of the prosthetic valve with respect to the nativevalve, by the native valve leaflets closing around the outer surface ofthe prosthetic valve.

For some applications, the expansion of prosthetic valve 80 againstvalve support 40 couples the prosthetic valve to the valve support,and/or couples the valve and the valve support to the native mitralvalve. Typically, the expansion of the prosthetic valve against thevalve support couples the prosthetic valve to the valve support, andsandwiching of the native valve leaflets between protrusions from thedistal end of the valve and the valve support couples the prostheticvalve and the valve support to the native valve.

Reference is now made to FIGS. 1A-D, 2A-K, 3A-D, 4A-C, 5A-D, 6A-B, 7A-F,8A-C, 9A-H, 10, 11A-D, and 12A-C. It is to be noted that valve support40 may be invertible as described hereinabove with respect to valvesupports 140 and 300, with reference to FIGS. 8A-C, and 9A-H. It is tobe further noted that valve supports 140 and 300 may be used inconjunction with one or more of the elements for facilitating sealing ofthe native valve with respect to a valve support or a valve that isdescribed with reference to FIGS. 3A-D, 4A-C, 5A-D, and 6A-B. Forexample, valve supports 140 and 300 may be used with sealing balloon 90,commissural anchors 100 a and 100 b, grasping elements 106 a and 106 b,and/or sealing material 110. It is still further noted that valvesupports 140 and 300 may be implanted using a guide member that definesa looped portion between commissures 8 and 10, as described withreference to FIGS. 7A-F. It is further noted that any of theapplications described herein can be used in conjunction with valveshaving configurations as described with reference to FIGS. 10-12C.

The systems described herein are advanced toward valve 5 in atranscatheter procedure, as shown. It is to be noted, however, that thesystems described herein may be advanced using any suitable procedure,e.g., minimally-invasively (e.g., via a transeptal, a transatrial, atransapical, and/or a transaortic approach), or using an open-heartprocedure. It is to be further noted that valve supports and prostheticvalves herein may be used to replace native mitral valves or nativetricuspid valves.

Reference is now made to FIGS. 20A-B, which are schematic illustrationsof valve support 40 and prosthetic valve 80 coupled respectively to atricuspid valve, and to an aortic valve, in accordance with someapplications of the present invention. For some applications, valvesupport 40 and prosthetic valve 80 are deployed at a tricuspid valveand/or at an aortic valve using generally similar techniques to thosedescribed herein with reference to the deployment of the valve supportand the prosthetic valve at the mitral valve, mutatis mutandis.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1-63. (canceled)
 64. A method, for use at a mitral valve of a heart of asubject, the method comprising: advancing a transluminal sheath into afemoral vein of the subject, through an inferior vena cava of thesubject, into a right atrium of the subject, and transseptally into aleft atrium of the subject; advancing a distal end of asurrounding-sheath, having an anchor disposed therein, via a distal endof the transluminal sheath, into a left ventricle of the subject via acommissure of the mitral valve; while the distal end of thesurrounding-sheath is in the left ventricle, pulling thesurrounding-sheath proximally with respect to the anchor to expose theanchor; while the distal end of the surrounding-sheath is in the leftventricle, encircling mitral valve tissue that is within the leftventricle, by helically wrapping the anchor around the mitral valvetissue; and subsequently, extracting the surrounding-sheath from theheart.
 65. The method according to claim 64, wherein helically wrappingthe anchor comprises positioning the anchor such that a wider end of theanchor is upstream of a narrower end of the anchor.
 66. The methodaccording to claim 64, wherein helically wrapping the anchor comprisespositioning the anchor such that a curved portion of the anchor having agreater radius of curvature is upstream of a curved portion of theanchor having a smaller radius of curvature.
 67. The method according toclaim 64, further comprising, subsequently to the extracting of thesurrounding-sheath, advancing a guide wire through the transluminalsheath.
 68. The method according to claim 67, further comprising,subsequently to the advancing of the guide wire: advancing a prostheticvalve along the guide wire; and implanting the prosthetic valve in themitral valve such that the anchor facilitates anchoring of theprosthetic valve and sealing of the commissure.
 69. The method accordingto claim 64, further comprising, subsequently to the extracting of thesurrounding-sheath, implanting a prosthetic valve in the mitral valvesuch that the anchor facilitates anchoring of the prosthetic valve andsealing of the commissure.